Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06446427
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants cannot be masked to whether they are at high or low altitude and whether they have spent a night at high altitude. However, they will not know whether they receive air (baseline, interventions 1 and 3) or supplementary oxygen nasally at the same flow rate (intervention 2).\n\nOutcome Assessors will be fully blinded. They assess the medical performance on video recordings of the simulated scenarios, and will not know which time point a specific scenario has taken place (baseline, interventions 1-3) and whether participants receive air or supplementary oxygen.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The investigators imply a repeated measures design. A group of 20 participants will perform in simulated medical scenarios sequentially under four different circumstances (baseline, interventions 1-3)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of acute high altitude exposure on medical performance, measured by the STAT score', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude)', 'description': 'The investigators asses the quality of patient care at low and high altitude exposure.\n\nThe primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.\n\nThe analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.'}, {'measure': 'The effect of acute high altitude exposure on medical performance, measured by the CALM score', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude)', 'description': 'The investigators asses the quality of patient care at low and high altitude exposure.\n\nThe primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.\n\nThe analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.'}, {'measure': 'The effect of acute high altitude exposure on medical performance, measured by the TEAM score', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude)', 'description': 'The investigators asses the quality of patient care at low and high altitude exposure.\n\nThe primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.\n\nThe analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.'}], 'secondaryOutcomes': [{'measure': 'The effect of supplementary oxygen on medical performance during acute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen)', 'description': 'The investigators asses any changes to the quality of patient care when participants receive supplementary oxygen during acute high altitude exposure. Since acute effects of high altitude exposure are mainly due to hypobaric hypoxia, supplementary oxygen might improve patient care. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).\n\nThe investigators use the same linear mixed-effect regression model as described under the primary outcome for the assessment of this outcome, but comparing intervention 2 (4 hours after arrival at high altitude, with supplementary oxygen) to baseline) and intervention 1 (at 30 minutes after arrival at high altitude).'}, {'measure': 'The effect of subacute high altitude exposure on medical performance, measured as a composite of STAT, CALM, and TEAM scores', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 3 (after having spent a night at high altitude)', 'description': 'The investigators asses the quality of patient care under subacute high altitude exposure, i.e. after having spent a night at high altitude. At the altitude at which the study takes place, 30-40% of participants are expected to develop mild to moderate symptoms of acute mountain sickness, which might impair the quality of patient care they provide. The presence and severity of AMS will be assessed by the Lake Louis Score. AMS is present at a score of 3 or higher. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).\n\nThe investigators use the same linear mixed-effect regression model as described under the primary outcome for the assessment of this outcome, but comparing intervention 3 (after having spent a night at high altitude, no supplementary oxygen) to baseline and intervention 1 (at 30 minutes after arrival at high altitude).'}, {'measure': 'The effect of gender and age on medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)', 'description': 'The impact of age and sex on medical performance during all points of testing (baseline, interventions 1-3) will be analysed by including the interactions of two variables (age and sex) with the fixed effect (representing the four time points) in the linear mixed-effect regression model described under the primary outcome. The statistical significance of the interaction will be assessed with a likelihood ratio test.\n\nPatient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).'}, {'measure': 'The correlations between psychomotor test results (PVT, BART, DSST, self-assessment of cognitive function) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)', 'description': 'Cognitive functions, such as measured by the psychomotor tests the investigators imply, can be impaired by high altitude exposure. The Psychomotor Vigilance Test (PVT) measures reaction speed in milliseconds. The Balloon Analogue Risk Task (BART) measures risk-taking behaviour in three numerical outcome variables. The Digit Symbol Substitution Test (DSST) measures cognitive performance and has a number of correct answers the participant found as its outcome. Participants will also self-assess their cognitive function on a scale of 1 to 10.\n\nThe investigators will look for statistical correlations between the results of psychomotor testing (PVT, BART, DSST) and the self-assessment of cognitive capacity, and the quality of patient care at all four time points (baseline, interventions 1-3). Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).'}, {'measure': 'The correlations between vital parameters (blood pressure, heart rate, peripheral blood oxygen saturation) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores', 'timeFrame': 'Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)', 'description': 'The investigators will measure basic vital parameters of participants (blood pressure, heart rate, and peripheral blood oxygen saturation) by non-invasive means at all time points of testing (baseline, interventions 1-3). They will look for correlations between those parameters and the medical performance. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Altitude', 'Hypobaric Hypoxia', 'Patient Care', 'Patient Safety', 'Rescuer Safety', 'Emergency Medicine', 'Anaesthesia'], 'conditions': ['High Altitude', 'Hypobaric Hypoxia', 'Risk Reduction']}, 'referencesModule': {'references': [{'pmid': '37833187', 'type': 'BACKGROUND', 'citation': 'Luks AM, Beidleman BA, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention, Diagnosis, and Treatment of Acute Altitude Illness: 2024 Update. Wilderness Environ Med. 2024 Mar;35(1_suppl):2S-19S. doi: 10.1016/j.wem.2023.05.013. Epub 2023 Dec 27.'}, {'pmid': '28111267', 'type': 'BACKGROUND', 'citation': 'McMorris T, Hale BJ, Barwood M, Costello J, Corbett J. Effect of acute hypoxia on cognition: A systematic review and meta-regression analysis. Neurosci Biobehav Rev. 2017 Mar;74(Pt A):225-232. doi: 10.1016/j.neubiorev.2017.01.019. Epub 2017 Jan 19.'}, {'pmid': '34093227', 'type': 'BACKGROUND', 'citation': 'Shaw DM, Cabre G, Gant N. Hypoxic Hypoxia and Brain Function in Military Aviation: Basic Physiology and Applied Perspectives. Front Physiol. 2021 May 17;12:665821. doi: 10.3389/fphys.2021.665821. eCollection 2021.'}, {'pmid': '29789086', 'type': 'BACKGROUND', 'citation': 'Bouak F, Vartanian O, Hofer K, Cheung B. Acute Mild Hypoxic Hypoxia Effects on Cognitive and Simulated Aircraft Pilot Performance. Aerosp Med Hum Perform. 2018 Jun 1;89(6):526-535. doi: 10.3357/AMHP.5022.2018.'}, {'pmid': '35640630', 'type': 'BACKGROUND', 'citation': 'Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31.'}, {'pmid': '32479806', 'type': 'BACKGROUND', 'citation': "Walsh JJ, Drouin PJ, King TJ, D'Urzo KA, Tschakovsky ME, Cheung SS, Day TA. Acute aerobic exercise impairs aspects of cognitive function at high altitude. Physiol Behav. 2020 Sep 1;223:112979. doi: 10.1016/j.physbeh.2020.112979. Epub 2020 May 29."}, {'pmid': '11239664', 'type': 'BACKGROUND', 'citation': 'Bolmont B, Thullier F, Abraini JH. 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Wilderness Environ Med. 2012 Jun;23(2):161-4. doi: 10.1016/j.wem.2012.02.001.'}, {'pmid': '37875893', 'type': 'BACKGROUND', 'citation': 'Niederer M, Tscherny K, Burger J, Wandl B, Fuhrmann V, Kienbacher CL, Schreiber W, Herkner H, Roth D, Egger A. Influence of high altitude after a prior ascent on physical exhaustion during cardiopulmonary resuscitation: a randomised crossover alpine field experiment. Scand J Trauma Resusc Emerg Med. 2023 Oct 24;31(1):59. doi: 10.1186/s13049-023-01132-7.'}, {'pmid': '29352676', 'type': 'BACKGROUND', 'citation': 'Sato T, Takazawa T, Inoue M, Tada Y, Suto T, Tobe M, Saito S. Cardiorespiratory dynamics of rescuers during cardiopulmonary resuscitation in a hypoxic environment. Am J Emerg Med. 2018 Sep;36(9):1561-1564. doi: 10.1016/j.ajem.2018.01.029. Epub 2018 Jan 8.'}, {'pmid': '32044210', 'type': 'BACKGROUND', 'citation': 'Suto T, Saito S, Tobe M, Kanamoto M, Matsui Y. Reduction of Arterial Oxygen Saturation Among Rescuers During Cardiopulmonary Resuscitation in a Hypobaric Hypoxic Environment. Wilderness Environ Med. 2020 Mar;31(1):97-100. doi: 10.1016/j.wem.2019.10.008. Epub 2020 Feb 7.'}, {'pmid': '32143653', 'type': 'BACKGROUND', 'citation': 'Egger A, Niederer M, Tscherny K, Burger J, Fuhrmann V, Kienbacher C, Roth D, Schreiber W, Herkner H. Influence of physical strain at high altitude on the quality of cardiopulmonary resuscitation. Scand J Trauma Resusc Emerg Med. 2020 Mar 6;28(1):19. doi: 10.1186/s13049-020-0717-0.'}, {'pmid': '34854317', 'type': 'BACKGROUND', 'citation': 'Vogele A, van Veelen MJ, Dal Cappello T, Falla M, Nicoletto G, Dejaco A, Palma M, Hufner K, Brugger H, Strapazzon G. Effect of Acute Exposure to Altitude on the Quality of Chest Compression-Only Cardiopulmonary Resuscitation in Helicopter Emergency Medical Services Personnel: A Randomized, Controlled, Single-Blind Crossover Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e021090. doi: 10.1161/JAHA.121.021090. Epub 2021 Dec 2.'}, {'pmid': '31911060', 'type': 'BACKGROUND', 'citation': 'Carballo-Fazanes A, Barcala-Furelos R, Eiroa-Bermudez J, Fernandez-Mendez M, Abelairas-Gomez C, Martinez-Isasi S, Murciano M, Fernandez-Mendez F, Rodriguez-Nunez A. Physiological demands of quality cardiopulmonary resuscitation performed at simulated 3250 meters high. Am J Emerg Med. 2020 Dec;38(12):2580-2585. doi: 10.1016/j.ajem.2019.12.048. Epub 2019 Dec 24.'}, {'pmid': '31876668', 'type': 'BACKGROUND', 'citation': 'Sareban M, Schiefer LM, Macholz F, Schafer L, Zangl Q, Inama F, Reich B, Mayr B, Schmidt P, Hartl A, Bartsch P, Niebauer J, Treff G, Berger MM. Endurance Athletes Are at Increased Risk for Early Acute Mountain Sickness at 3450 m. Med Sci Sports Exerc. 2020 May;52(5):1109-1115. doi: 10.1249/MSS.0000000000002232.'}, {'pmid': '21190503', 'type': 'BACKGROUND', 'citation': 'Mairer K, Wille M, Burtscher M. 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Print 2017 Jan.'}, {'pmid': '30479778', 'type': 'BACKGROUND', 'citation': 'Kammerer T, Faihs V, Hulde N, Bayer A, Hubner M, Brettner F, Karlen W, Kropfl JM, Rehm M, Spengler C, Schafer ST. Changes of hemodynamic and cerebral oxygenation after exercise in normobaric and hypobaric hypoxia: associations with acute mountain sickness. Ann Occup Environ Med. 2018 Nov 19;30:66. doi: 10.1186/s40557-018-0276-2. eCollection 2018.'}, {'pmid': '28509579', 'type': 'BACKGROUND', 'citation': 'Phillips L, Basnyat B, Chang Y, Swenson ER, Harris NS. Findings of Cognitive Impairment at High Altitude: Relationships to Acetazolamide Use and Acute Mountain Sickness. High Alt Med Biol. 2017 Jun;18(2):121-127. doi: 10.1089/ham.2016.0001. Epub 2017 May 16.'}, {'pmid': '27460198', 'type': 'BACKGROUND', 'citation': 'Issa AN, Herman NM, Wentz RJ, Taylor BJ, Summerfield DC, Johnson BD. Association of Cognitive Performance with Time at Altitude, Sleep Quality, and Acute Mountain Sickness Symptoms. Wilderness Environ Med. 2016 Sep;27(3):371-8. doi: 10.1016/j.wem.2016.04.008. Epub 2016 Jul 22.'}, {'pmid': '30246787', 'type': 'BACKGROUND', 'citation': 'Pun M, Guadagni V, Bettauer KM, Drogos LL, Aitken J, Hartmann SE, Furian M, Muralt L, Lichtblau M, Bader PR, Rawling JM, Protzner AB, Ulrich S, Bloch KE, Giesbrecht B, Poulin MJ. Effects on Cognitive Functioning of Acute, Subacute and Repeated Exposures to High Altitude. Front Physiol. 2018 Aug 21;9:1131. doi: 10.3389/fphys.2018.01131. eCollection 2018.'}, {'pmid': '29628892', 'type': 'BACKGROUND', 'citation': 'Moraga FA, Lopez I, Morales A, Soza D, Noack J. The Effect of Oxygen Enrichment on Cardiorespiratory and Neuropsychological Responses in Workers With Chronic Intermittent Exposure to High Altitude (ALMA, 5,050 m). 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Prevalence and knowledge about acute mountain sickness in the Western Alps. PLoS One. 2023 Sep 14;18(9):e0291060. doi: 10.1371/journal.pone.0291060. eCollection 2023.'}, {'pmid': '22198422', 'type': 'BACKGROUND', 'citation': 'Reid J, Stone K, Brown J, Caglar D, Kobayashi A, Lewis-Newby M, Partridge R, Seidel K, Quan L. The Simulation Team Assessment Tool (STAT): development, reliability and validation. Resuscitation. 2012 Jul;83(7):879-86. doi: 10.1016/j.resuscitation.2011.12.012. Epub 2011 Dec 23.'}, {'pmid': '29117092', 'type': 'BACKGROUND', 'citation': 'Nadkarni LD, Roskind CG, Auerbach MA, Calhoun AW, Adler MD, Kessler DO. The Development and Validation of a Concise Instrument for Formative Assessment of Team Leader Performance During Simulated Pediatric Resuscitations. Simul Healthc. 2018 Apr;13(2):77-82. doi: 10.1097/SIH.0000000000000267.'}, {'pmid': '35533136', 'type': 'BACKGROUND', 'citation': 'Florez AR, Shepard LN, Frey ME, Justice LB, Constand SE, Gilbert GE, Kessler DO, Kerrey BT, Calhoun AW. The Concise Assessment of Leader Management Tool: Evaluation of Healthcare Provider Leadership During Real-Life Pediatric Emergencies. Simul Healthc. 2023 Feb 1;18(1):24-31. doi: 10.1097/SIH.0000000000000669. Epub 2022 May 5.'}, {'pmid': '20117874', 'type': 'BACKGROUND', 'citation': 'Cooper S, Cant R, Porter J, Sellick K, Somers G, Kinsman L, Nestel D. Rating medical emergency teamwork performance: development of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2010 Apr;81(4):446-52. doi: 10.1016/j.resuscitation.2009.11.027. Epub 2010 Feb 1.'}, {'pmid': '36405618', 'type': 'BACKGROUND', 'citation': "Gawronski O, Thekkan KR, Genna C, Egman S, Sansone V, Erba I, Vittori A, Varano C, Dall'Oglio I, Tiozzo E, Chiusolo F. Instruments to evaluate non-technical skills during high fidelity simulation: A systematic review. Front Med (Lausanne). 2022 Nov 3;9:986296. doi: 10.3389/fmed.2022.986296. eCollection 2022."}, {'pmid': '24152275', 'type': 'BACKGROUND', 'citation': 'Bartsch P, Swenson ER. Acute high-altitude illnesses. N Engl J Med. 2013 Oct 24;369(17):1666-7. doi: 10.1056/NEJMc1309747. No abstract available.'}, {'pmid': '19099331', 'type': 'BACKGROUND', 'citation': 'Stream JO, Grissom CK. Update on high-altitude pulmonary edema: pathogenesis, prevention, and treatment. Wilderness Environ Med. 2008 Winter;19(4):293-303. doi: 10.1580/07-WEME-REV-173.1.'}, {'pmid': '15703168', 'type': 'BACKGROUND', 'citation': 'Bartsch P, Mairbaurl H, Maggiorini M, Swenson ER. Physiological aspects of high-altitude pulmonary edema. J Appl Physiol (1985). 2005 Mar;98(3):1101-10. doi: 10.1152/japplphysiol.01167.2004.'}]}, 'descriptionModule': {'briefSummary': 'Rescue services in mountainous regions are frequently called to missions at altitudes \\>3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures. Previous studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have found that the lack of oxygen associated with acute exposure to altitude may impair cognitive functions. No data exists on the effect this may have on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The investigators of this study aim to make rescue missions to high altitude safer for both the patients and the rescuers.\n\nTo assess the effect of high altitude on patient care, the investigators recruit highly trained medical specialists who will perform patient care in simulated scenarios both at high altitude and at low altitude. These scenarios will be recorded and the performance of the medical specialists judged by independent reviewers.\n\nThe medical specialists will also perform in simulated scenarios at high altitude two more times: once with supplementary oxygen, and once after spending a night at high altitude. the investigators do this to evaluate whether supplementary oxygen improves their performance, and whether symptoms of acute mountain sickness (which usually develop after spending the first night at high altitude) decreases their performance further.', 'detailedDescription': 'Rescue services in mountainous regions are frequently called to missions at altitudes \\>3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures, such as an emergency induction of anaesthesia, resuscitation, treatment of polytraumatized patients, or a winch manoeuvre by helicopter in exposed, fall-prone terrain.\n\nThe exponential decrease in barometric pressure at altitude results in hypobaric hypoxia (HH), leading to a reduction in the partial pressure of oxygen at every point along the oxygen transport chain from the ambient air to tissue mitochondria. If the body\'s adaptive mechanisms fail to compensate for the lack of oxygen, symptoms like headache, nausea, fatigue, and dizziness may occur. In addition, HH may impair higher cortical functions. Individuals affected by high altitude frequently do not recognise a decline in cognitive function and overall performance, which can lead to incidents and even fatal consequences.\n\nPrevious studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have explored the influence of HH on multiple cognitive domains. Impairment of working memory was described during hypoxia awareness trainings and in pilots while others reported no effects. Some studies have reported reduced psychomotor vigilance, while others found no effects. To counteract these impairments, the European Union Aviation Safety Agency (EASA) mandates simulated hypoxia training for pilots flying rescue missions to above 4000 m.\n\nStudies in medical personnel are few and mostly focused on the quality of cardiopulmonary resuscitation (CPR) at (simulated) high altitude. High-quality CPR, which can be physically demanding for rescuers even under normoxic conditions, leads to rescuer fatigue faster under HH. Two recent studies have shown that HH leads to a lower quality of CPR at simulated and natural high altitude. A smaller study found simulated altitude to have a negative effect on the quality of ventilation but not on chest compression. A recent study reported a slower reaction time in medical personnel at simulated high altitude. Particularly noteworthy is the fact that rescuers did neither notice the reduced cognitive function nor the decreased quality of CPR they provided under HH, even though they were highly trained helicopter emergency medical services personnel. To the investigators\' knowledge, CPR at high altitude has only been studied as an isolated skill. No data exist on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The findings of this study may help to broaden the understanding of HH, and lay the ground for further research in high altitude rescue.\n\nAs the primary endpoint of this study, the investigators evaluate medical performance and patient care using validated scores for medical skills and non-technical skills (Modified Simulation Team Assessment Tool (STAT), Concise Assessment of Leader Management (CALM), Team Emergency Assessment Measure (TEAM). These three scores are averaged (25% STAT, 25% CALM, 50% TEAM) to form a composite score. Scores are assessed by an analysis of video recordings of the simulated scenarios by independent outside assessors.\n\nSecondary endpoints are described in detail elsewhere. They involve the measurement of reaction speed, risk assessment ability, cognitive function, the presence/absence of acute mountain sickness (AMS), the self-assessment of cognitive capacity, and basic vital functions. The concrete tests and measurements the investigators imply are:\n\n* Psychomotor Vigilance Test (PVT)\n* Balloon Analogue Risk Task (BART)\n* Digit Symbol Substitution Test (DSST)\n* Lake Louis Score (LLS), AMS is present at a score of three or higher\n* Self-Assessment of Cognitive Capacity on a scale of 1-10\n* Heart rate, Blood-pressure, peripheral blood oxygen saturation (SpO2) as measured by non-invasive means\n\nThe investigators will assess medical performance (and all other tests and measurements mentioned above) at four time points (baseline, interventions 1-3).\n\nTesting at 30 minutes after arrival by train at high altitude (the High Altitude Research Station Jungfraujoch, 3450 m, "intervention 1") and at low altitude (Bern, 540 m, "baseline") are performed to answer the main hypothesis; whether acute rescuer exposure to high altitude impairs patient care.\n\nTo answer the additional research questions, additional testing will be performed at high altitude 4 hours after arrival with supplemental oxygen (4 litres/min, nasal) ("intervention 2") and after spending the night at 3450 m ("intervention 4").\n\nAt the four time points of measurement, the participants will have to run through one of the following four scenarios of simulated patient care:\n\n1. A polytraumatised 35 y.o. patient who fell 12 metres. Adequate treatment will entail: anamnesis, immobilisation of the cervical spine, treatment of a tension pneumothorax, installation of analgosedation.\n2. A 64 y.o. patient with acute abdominal pain and nausea due to an acute myocardial infarction. Adequate treatment will entail: Anamnesis, performing and interpreting a 12-lead electrocardiogram, resuscitation.\n3. A 35 y.o. mother with her 5 m.o. child who is experiencing a seizure. Adequate treatment will entail: Anamnesis, treatment of the epileptic seizure, recognition of impeding respiratory failure and consequent assisted ventilation.\n4. A 19 y.o. hypothermic patient. Adequate treatment will entail: Anamnesis, recognition of likely hypothermia and taking measures to avoid afterdrop, resuscitation according to hypothermia protocols, adequate care after return of spontaneous circulation.\n\nAll four scenarios are designed to be of equal difficulty. However, the order of the scenarios is randomised electronically before the start of the study, so that different participants go through different scenarios at all points of measurements (baseline, interventions 1-3). This is done to avoid skewing of performance due to some scenarios being inadvertently more difficult or easier than others.\n\nBefore each scenario, the participants undergo all tests and measurements outlined above (PVT, BART, DSST, LLS, Self-Assessment of Cognitive Capacity on a scale of 1-10, Heart rate, Blood-pressure, peripheral blood oxygen saturation).\n\nSupplemental application of oxygen during intervention 2 might bias the participants. Therefore, they will receive air via nasal cannula at the same flow rate during all other scenarios (baseline, interventions 1 and 3) in the sense of a "placebo administration".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMedical doctors with certification and experience in preclinical emergency medicine, defined as (all must apply):\n\n* 2 or more years of training in anaesthesiology\n* 3 or more months of preclinical work\n* 50 or more cases as the lead preclinical physician with potential danger to the patient\'s life (with a National Advisory Committee for Aeronautics score (NACA) of 4 or more)\n* A valid preclinical certification (Swiss "Notarztkurs" or similar)\n* Written informed consent to participate in the study\n\nExclusion Criteria (none must apply):\n\n* Any medical condition known to place the participant at higher risk for hypoxia-induced adverse events (cardiovascular, pulmonary, neurological, otherwise).\n* Pre-acclimatisation to high altitude, defined as travel to above 2500 m in the 4 weeks previous to the study'}, 'identificationModule': {'nctId': 'NCT06446427', 'briefTitle': 'The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care', 'orgStudyIdInfo': {'id': '2024-00237'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acute high altitude exposure', 'type': 'OTHER', 'otherNames': ['Intervention 1'], 'description': 'Thirty minutes after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 1", high altitude at 3450 masl) is performed.'}, {'name': 'Acute high altitude exposure, with supplementary oxygen', 'type': 'OTHER', 'otherNames': ['Intervention 2'], 'description': '4 hours after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 2", high altitude at 3450 masl) is performed, while the participants receive 4 litres / minute of oxygen via nasal route.'}, {'name': 'Subacute high altitude exposure, after having spent a night at high altitude', 'type': 'OTHER', 'otherNames': ['Intervention 3'], 'description': 'After having spent a night at the Research Station Jungfraujoch, a simulated scenario of patient care ("Intervention 3", high altitude at 3450 masl) is performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Berner Simulations- und CPR-Zentrum BeSiC', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '3012', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'High Altitude Research Station Jungfraujoch', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Juergen Knapp, PD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Bern (Inselspital), Department of Anaesthesiology and Pain Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data (IPD) will be shared in the primary publication(s). IPD can be made available at a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}