Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 10:47 PM
Study NCT ID:
NCT07299968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard)', 'timeFrame': 'During the emergency department visit (single measurement per participant).', 'description': 'Respiratory rate will be measured simultaneously using the Welch Allyn Connex Spot Monitor and by trained observers performing manual counting over 60 seconds. Agreement between the two methods will be assessed using the Intraclass Correlation Coefficient and Bland-Altman analysis to evaluate bias and limits of agreement.'}], 'secondaryOutcomes': [{'measure': 'Agreement between respiratory rate values measured by trained observers and those recorded by triage nurses during triage', 'timeFrame': 'During the emergency department visit (single measurement per participant).', 'description': 'Respiratory rate measurements recorded by triage nurses during triage will be compared with manual 60-second counts performed by trained observers. Agreement between the two methods will be evaluated using the Intraclass Correlation Coefficient and Bland-Altman analysis to assess bias and limits of agreement.'}, {'measure': 'Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers in patients with ECG-confirmed arrhytmias', 'timeFrame': 'During the emergency department visit (single measurement per participant).', 'description': 'Respiratory rate measurements recorded by triage nurses during triage will be compared with manual 60-second spot measurements performed by trained observers. Agreement between the two methods will be evaluated using the Intraclass Correlation Coefficient and Bland-Altman analysis to assess bias and limits of agreement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory rate', 'emergency department', 'Welch'], 'conditions': ['Respiratory Rate', 'Breathing Rate']}, 'referencesModule': {'references': [{'pmid': '23197319', 'type': 'BACKGROUND', 'citation': 'Semler MW, Stover DG, Copland AP, Hong G, Johnson MJ, Kriss MS, Otepka H, Wang L, Christman BW, Rice TW. Flash mob research: a single-day, multicenter, resident-directed study of respiratory rate. Chest. 2013 Jun;143(6):1740-1744. doi: 10.1378/chest.12-1837.'}, {'pmid': '35944945', 'type': 'BACKGROUND', 'citation': 'Loots FJ, Dekker I, Wang RC, van Zanten AR, Hopstaken RM, Verheij TJ, Giesen P, Smits M. The accuracy and feasibility of respiratory rate measurements in acutely ill adult patients by GPs: a mixed-methods study. BJGP Open. 2022 Dec 20;6(4):BJGPO.2022.0029. doi: 10.3399/BJGPO.2022.0029. Print 2022 Dec.'}, {'pmid': '11867974', 'type': 'BACKGROUND', 'citation': 'Edmonds ZV, Mower WR, Lovato LM, Lomeli R. The reliability of vital sign measurements. Ann Emerg Med. 2002 Mar;39(3):233-7. doi: 10.1067/mem.2002.122017.'}, {'pmid': '28652259', 'type': 'BACKGROUND', 'citation': 'Badawy J, Nguyen OK, Clark C, Halm EA, Makam AN. Is everyone really breathing 20 times a minute? Assessing epidemiology and variation in recorded respiratory rate in hospitalised adults. BMJ Qual Saf. 2017 Oct;26(10):832-836. doi: 10.1136/bmjqs-2017-006671. Epub 2017 Jun 26.'}, {'pmid': '18522524', 'type': 'BACKGROUND', 'citation': 'Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15.'}, {'pmid': '22584764', 'type': 'BACKGROUND', 'citation': 'Churpek MM, Yuen TC, Park SY, Meltzer DO, Hall JB, Edelson DP. Derivation of a cardiac arrest prediction model using ward vital signs*. Crit Care Med. 2012 Jul;40(7):2102-8. doi: 10.1097/CCM.0b013e318250aa5a.'}, {'pmid': '15918825', 'type': 'BACKGROUND', 'citation': 'Goldhill DR, McNarry AF, Mandersloot G, McGinley A. A physiologically-based early warning score for ward patients: the association between score and outcome. Anaesthesia. 2005 Jun;60(6):547-53. doi: 10.1111/j.1365-2044.2005.04186.x.'}, {'pmid': '29123857', 'type': 'BACKGROUND', 'citation': 'Mochizuki K, Shintani R, Mori K, Sato T, Sakaguchi O, Takeshige K, Nitta K, Imamura H. Importance of respiratory rate for the prediction of clinical deterioration after emergency department discharge: a single-center, case-control study. Acute Med Surg. 2016 Nov 10;4(2):172-178. doi: 10.1002/ams2.252. eCollection 2017 Apr.'}, {'pmid': '10403864', 'type': 'BACKGROUND', 'citation': 'Goldhill DR, White SA, Sumner A. Physiological values and procedures in the 24 h before ICU admission from the ward. Anaesthesia. 1999 Jun;54(6):529-34. doi: 10.1046/j.1365-2044.1999.00837.x.'}], 'seeAlsoLinks': [{'url': 'https://www.hillrom.com/en/products/connex-spot-monitor/', 'label': 'Product page for the Welch Allyn Connex Spot Monitor'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study will evaluate the accuracy of the Welch Allyn Connex Spot Monitor equipped with a Masimo SpO₂ finger sensor in measuring respiratory rate in the emergency department. Respiratory rate is a key predictor of patient deterioration, yet it is frequently measured inaccurately when assessed manually. In this study, respiratory rate values obtained by the monitor will be compared against manual counts performed by trained observers (physicians). An additional analysis will compare respiratory rates measured by trained observers with those recorded by triage nurses during triage. A subgroup analysis will also investigate whether cardiac arrhythmias influence measurement accuracy.\n\nThe aim is to examine if respiratory rates measured by the Welch Allyn Connex Spot Monitor are comparable to those obtained by trained observers and triage nurses in the emergency department.', 'detailedDescription': 'Design: prospective observational method comparison study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted on patients admitted to the Emergency Department of Semmelweis University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- all patients aged ≥18 years.\n\nExclusion Criteria:\n\n* patients receiving invasive or non-invasive respiratory support;\n* patients with disorders causing involuntary movements;\n* skin or digit abnormalities preventing proper application of the pulse oximeter;\n* clinically unstable patients on arrival (requiring immediate transfer to the resuscitation area);\n* patients with a left ventricular assist device (LVAD).'}, 'identificationModule': {'nctId': 'NCT07299968', 'briefTitle': 'Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol', 'orgStudyIdInfo': {'id': 'SOK-LEGZ25'}}, 'contactsLocationsModule': {'locations': [{'zip': '1082', 'city': 'Budapest', 'country': 'Hungary', 'contacts': [{'name': 'Alexandra K Csapó', 'role': 'CONTACT', 'email': 'csapo.alexandra.klaudia@semmelweis.hu', 'phone': '+36208250581'}, {'name': 'Gabriella Anna Rapszky, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Emergency Medicine, Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Bánk G Fenyves, MD, PhD', 'role': 'CONTACT', 'email': 'fenyves.bank@semmelweis.hu', 'phone': '+3630016414'}, {'name': 'Gabriella A Rapszky, MD', 'role': 'CONTACT', 'email': 'rapszky.gabriella.anna@semmelweis.hu', 'phone': '+36305742899'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Rapszky Gabriella Anna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Semmelweis University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'subinvestigator (PhD student, resident)', 'investigatorFullName': 'Dr. Rapszky Gabriella Anna', 'investigatorAffiliation': 'Semmelweis University'}}}}