Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-26 @ 7:25 PM
Study NCT ID:
NCT02001792
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2012-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2012-04-14', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy', 'timeFrame': 'participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour', 'description': 'saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': '1 day', 'description': 'Adenoma detection rate between the two arms will be compared at the end of the investigation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sedation', 'endoscopy', 'patient positioning', 'hypoxemia'], 'conditions': ['Sedation Problems', 'Breathing Complications']}, 'referencesModule': {'references': [{'pmid': '26126161', 'type': 'DERIVED', 'citation': 'Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.', 'detailedDescription': 'Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colonoscopy indicated\n\nExclusion Criteria:\n\n* patient denies sedation\n* prior saturation \\< 90%\n* prior heart rate \\< 50 bpm\n* prior blood pressure \\< 90 mmHg'}, 'identificationModule': {'nctId': 'NCT02001792', 'acronym': 'PACSO', 'briefTitle': 'Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'orgStudyIdInfo': {'id': 'PatPo2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Controll group', 'description': 'Patients lying in a supine position during colonoscopy', 'interventionNames': ['Device: pulse oximeter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Patients lying in a left lateral position during colonoscopy', 'interventionNames': ['Procedure: Position the patient during colonoscopy', 'Device: pulse oximeter']}], 'interventions': [{'name': 'Position the patient during colonoscopy', 'type': 'PROCEDURE', 'description': 'Position the patient either in a left lateral position during colonoscopy', 'armGroupLabels': ['Intervention']}, {'name': 'pulse oximeter', 'type': 'DEVICE', 'armGroupLabels': ['Controll group', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Prien am Chiemsee', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Krankenhaus Prien', 'geoPoint': {'lat': 47.85602, 'lon': 12.34623}}], 'overallOfficials': [{'name': 'Peter Klare, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany'}, {'name': 'Stefan von Delius, PD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}