Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 9:38 AM
Study NCT ID:
NCT01049958
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000097742', 'term': 'Patient-Ventilator Asynchrony'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-13', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of asynchronous breaths', 'timeFrame': '20 minutes during first 24 hours on ventilation and 20 minutes during weaning phase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asynchrony', 'mechanical ventilation', 'blunt trauma'], 'conditions': ['Patient/Ventilator Asynchrony']}, 'referencesModule': {'references': [{'pmid': '16896854', 'type': 'BACKGROUND', 'citation': 'Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.'}, {'pmid': '7750336', 'type': 'BACKGROUND', 'citation': 'Fabry B, Guttmann J, Eberhard L, Bauer T, Haberthur C, Wolff G. An analysis of desynchronization between the spontaneously breathing patient and ventilator during inspiratory pressure support. Chest. 1995 May;107(5):1387-94. doi: 10.1378/chest.107.5.1387.'}, {'pmid': '9032512', 'type': 'BACKGROUND', 'citation': 'Nava S, Bruschi C, Fracchia C, Braschi A, Rubini F. Patient-ventilator interaction and inspiratory effort during pressure support ventilation in patients with different pathologies. Eur Respir J. 1997 Jan;10(1):177-83. doi: 10.1183/09031936.97.10010177.'}, {'pmid': '23513248', 'type': 'DERIVED', 'citation': 'Robinson BR, Blakeman TC, Toth P, Hanseman DJ, Mueller E, Branson RD. Patient-ventilator asynchrony in a traumatically injured population. Respir Care. 2013 Nov;58(11):1847-55. doi: 10.4187/respcare.02237. Epub 2013 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the prevalence of patient-ventilator asynchrony and its determinants. Mechanically ventilated trauma patients often experience asynchrony when their pattern of breathing does not match the triggering of a mechanical ventilator.\n\nAsynchrony is thought to be more common in delirious patients, patients with chronic lung disease and those who are heavily sedated. The study will examine the relationship between (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.', 'detailedDescription': 'This is a prospective observational study to determine the prevalence of patient/ventilator asynchrony in a cohort of trauma and surgical patients. There will be two 20-minute periods of observation. The first will be during the first 24 hours of mechanical ventilation and the second will take place when the patient is being weaned from the ventilator and is triggering half or more of all ventilator breaths.\n\nThe study team will use computer-captured waveforms to determine the proportion of all breaths that are asynchronous. This proportion is the primary outcome variable of the study.\n\nThe study hypothesis is that the proportion of asynchronous breaths is higher in patients with higher levels of sedation, as measured by the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Methods for the Intensive Care Unit (CAM-ICU). This hypothesis will be tested using repeated measures analysis of variance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Surgical and Neurosurgical Intensive Care Units at University Hospital, Cincinnati, OH, who require mechanical ventilation and are aged 18 years or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma or surgical diagnosis\n* Patients requiring mechanical ventilation\n\nExclusion Criteria:\n\n* Patients with no spontaneous breathing efforts due to injury or chemical paralysis\n* Patients with leaks in the patient ventilator system precluding evaluation of waveforms'}, 'identificationModule': {'nctId': 'NCT01049958', 'acronym': 'Asynchrony', 'briefTitle': 'Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Prevalence of Patient Ventilator Asynchrony in Trauma and Surgical Patients', 'orgStudyIdInfo': {'id': 'Robinson-2009-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Bryce Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}