Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 8:03 PM
Study NCT ID:
NCT02825433
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2016-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observing Changes in Ventilation Pattern During Procedural Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2016-06-25', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'Measured for every breath observed throughout the endoscopy procedure'}, {'measure': 'Tidal volume', 'timeFrame': 'Measured for every breath observed throughout the endoscopy procedure'}, {'measure': 'End-tidal CO2', 'timeFrame': 'Measured for every breath observed throughout the endoscopy procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Ventilation']}, 'descriptionModule': {'briefSummary': 'The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients receiving procedural sedation during endoscopy procedures in order to observe what changes commonly occur.', 'detailedDescription': 'The literature does not currently describe which ventilation changes a clinician should watch for to keep a patient safe during procedural sedation provided by fentanyl and propofol. This observational study aimed to record the breath-by-breath respiratory rate, tidal volume and end-tidal CO2 for each patient during procedural sedation for each endoscopy procedure. Data analysis offline will aim to identify any patterns in ventilation which may precede apnea or blood oxygen desaturation. The patterns in ventilation preceding apnea or blood oxygen saturation will be compared and contrasted with the patterns of ventilation during normal ventilation periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving procedural sedation for endoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (i) ASA I, II, or III\n* (ii) patients older than eighteen\n* (iii) English speaking\n* (iv) undergoing a colonoscopy procedure and receiving procedural sedation\n\nExclusion Criteria:\n\n* (i) inability/refusal of subject to provide informed consent\n* (ii) standard colonoscopy exclusion criteria used at the GI lab at the University of Utah\n* (iii) patients with severe medical conditions that in the view of the acting physician prohibits participation in the study'}, 'identificationModule': {'nctId': 'NCT02825433', 'briefTitle': 'Observing Changes in Ventilation Pattern During Procedural Sedation', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Observing Changes in Ventilation Pattern During Procedural Sedation', 'orgStudyIdInfo': {'id': 'IRB_00061832'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving procedural sedation', 'description': 'The investigators collected ventilation data for each breath (respiratory rate, tidal volume, and end-tidal CO2) for all patients receiving procedural sedation for endoscopy.', 'interventionNames': ['Other: No intervention, only ventilation monitoring']}], 'interventions': [{'name': 'No intervention, only ventilation monitoring', 'type': 'OTHER', 'armGroupLabels': ['Patients receiving procedural sedation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Professor', 'investigatorFullName': 'Lara Brewer', 'investigatorAffiliation': 'University of Utah'}}}}