Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT06531005
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Ventilation Parameters for Extubation Prediction in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-28', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation time', 'timeFrame': 'seven days', 'description': 'time patients will be extubated after intubation'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 days', 'description': '28 day mortality'}, {'measure': 'acute renal failure', 'timeFrame': 'one month', 'description': 'Number of patients who developed acute kidney injury according to KDIGO guidelines'}, {'measure': 'ICU/ hospital length of stay', 'timeFrame': 'three months', 'description': 'ICU/ hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory failure', 'extubation', 'mechanical power', 'elastic power', 'repiratory mechanics', 'outcome'], 'conditions': ['Acute Respiratory Failure', 'Invasive Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '20934212', 'type': 'BACKGROUND', 'citation': 'Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11.'}, {'pmid': '10793162', 'type': 'BACKGROUND', 'citation': 'Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.'}, {'pmid': '11991877', 'type': 'BACKGROUND', 'citation': 'de Durante G, del Turco M, Rustichini L, Cosimini P, Giunta F, Hudson LD, Slutsky AS, Ranieri VM. ARDSNet lower tidal volume ventilatory strategy may generate intrinsic positive end-expiratory pressure in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2002 May 1;165(9):1271-4. doi: 10.1164/rccm.2105050.'}, {'pmid': '25693014', 'type': 'BACKGROUND', 'citation': 'Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.'}, {'pmid': '31665612', 'type': 'BACKGROUND', 'citation': 'Marini JJ, Rocco PRM, Gattinoni L. Static and Dynamic Contributors to Ventilator-induced Lung Injury in Clinical Practice. Pressure, Energy, and Power. Am J Respir Crit Care Med. 2020 Apr 1;201(7):767-774. doi: 10.1164/rccm.201908-1545CI.'}, {'pmid': '27620287', 'type': 'RESULT', 'citation': 'Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.'}, {'pmid': '37480658', 'type': 'RESULT', 'citation': 'Xie Y, Yan Y, Shi J, Luo J, Wang Y, Chen H, Li X. Elastic power, a novel predictor of the severity and prognosis of ARDS. J Crit Care. 2023 Dec;78:154380. doi: 10.1016/j.jcrc.2023.154380. Epub 2023 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to research the values of mechanical power, driving pressure, and elastic power in predicting the duration of mechanical ventilation in critically ill patients undergoing invasive mechanical ventilation. This will help determine which patients may be considered for early extubation, which patients should wait for extubation, and the patients where extubation is anticipated to be prolonged, attention should be paid to initiating preparations for alternative treatment methods like tracheostomy early.', 'detailedDescription': 'Due to acute respiratory failure, mechanical ventilation support is provided to over 20 million patients worldwide. Therefore, various studies are being conducted to prevent ventilation-associated lung injury in patients receiving invasive mechanical ventilation, especially in conditions such as acute respiratory distress syndrome (ARDS).\n\nInitially, protective mechanical ventilation studies have shown that keeping plateau pressure (Pplat), reflecting static compliance, below 30 cmH2O along with low tidal volume reduces all-cause mortality. Subsequent studies have defined driving pressure as Pplato-PEEP, suggesting that keeping driving pressure below 15 cmH2O may reduce excessive strain on healthy lung tissue and the development of ventilator-associated lung injury.\n\nIn 2016, Gattinoni and colleagues defined mechanical power as the power applied by the ventilator to the entire respiratory system per minute during mechanical ventilation, prompting research into the relationship between mechanical power and mortality, particularly in ARDS.\n\nMechanical power consists of three components: energy delivered with each breath when PEEP is applied, energy applied to overcome airway resistance, and elastic energy delivered with each tidal breath.\n\nFinally, Yongpeng Xie and colleagues hypothesized that elastic power, normalized by compliance, has a more significant relationship with mortality in ARDS patients. Studies on mechanical power, driving pressure, and elastic power typically focus on values measured on the first day of intubation and are predominantly conducted in ARDS patients.\n\nBy including all patients under invasive mechanical ventilation in the study, the importance of measuring and monitoring mechanical ventilator parameters (mechanical power, driving pressure, and elastic power) at 0th, 24th, and 48th hours to predict extubation within the first week is being determined. This aims to identify when early extubation should be considered, when extubation should be delayed, and to prepare for alternative treatment options like tracheostomy in cases where extubation might be prolonged.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have recently been intubated for acute respiratory failure and admitted to participating ICUs will be screened and included in the study if eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consenting patients who have recently been intubated for acute respiratory failure\n\nExclusion Criteria:\n\n* patients with lung cancer/ lung metastasis\n* ECMO\n* death within 24 hours'}, 'identificationModule': {'nctId': 'NCT06531005', 'briefTitle': 'Assessment of Ventilation Parameters for Extubation Prediction in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Assessment of Ventilation Parameters for Extubation Prediction in ICU', 'orgStudyIdInfo': {'id': 'Respmechanics'}}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Altindağ', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Neriman D Altıntaş, Prof.Dr.', 'role': 'CONTACT', 'email': 'defne98hac@yahoo.com', 'phone': '+905326640331'}, {'name': 'Nuri İşler, Resid.Dr', 'role': 'CONTACT', 'phone': '+905078339595'}], 'facility': 'Ankara University Faculty of Medicine'}], 'centralContacts': [{'name': 'nuri işler, res.doctor', 'role': 'CONTACT', 'email': 'nuriisler1753@gmail.com', 'phone': '+905078339595'}, {'name': 'Nazlıhan B DÜNDAR, Ass.Prof.', 'role': 'CONTACT', 'email': 'nazlihan_boyaci@yahoo.com', 'phone': '+905054790794'}], 'overallOfficials': [{'name': 'Neriman D Altıntaş, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ankara.edu.tr/ndaltintas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Nuri Isler', 'investigatorAffiliation': 'Ankara University'}}}}