Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 10:45 AM
Study NCT ID:
NCT02619656
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-procedure pneumoperitoneum', 'timeFrame': 'left-lateral decubitus abdominal x-rays 30 min after PEG placement.', 'description': 'Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PEG', 'CO2 insufflation', 'Room Air insufflation', 'pneumoperitoneum'], 'conditions': ['Pneumoperitoneum']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.', 'detailedDescription': 'Background and study aims: Pneumoperitoneum following PEG placement has been reported in up to 60% of cases, and while usually benign and self-limited, it can lead to evaluation for suspected perforation. This study was designed to determine whether using CO2 compared to ambient air for insufflation during PEG reduces post-procedure pneumoperitoneum.\n\nPatients and Methods: Prospective, double blind, randomized trial of 35 consecutive patients undergoing PEG at a single academic medical center. Patients were randomized to insufflation with CO2 or ambient air. Primary outcome was pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. Secondary endpoints included abdominal distention, pain, and bloating.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02619656', 'briefTitle': 'A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '55102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients randomized to insufflation with CO2.\n\nIntervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min', 'interventionNames': ['Procedure: CO2 insufflation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients randomized to insufflation with ambient air.\n\nIntervention: Ambient air insufflation with Evis Exera 111 CLV-190 on medium air flow setting 0.68 L/min', 'interventionNames': ['Procedure: Ambient air insufflation']}], 'interventions': [{'name': 'CO2 insufflation', 'type': 'PROCEDURE', 'otherNames': ['CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min'], 'description': 'Patients were randomized to insufflation with CO2.', 'armGroupLabels': ['Treatment']}, {'name': 'Ambient air insufflation', 'type': 'PROCEDURE', 'otherNames': ['Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min'], 'description': 'Patients were randomized to insufflation with ambient air.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah SOM', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Christopher Murphy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah SOM'}, {'name': 'John C Fang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah SOM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Gastroenterology, Hepatology and Nutrition', 'investigatorFullName': 'John C. Fang, M.D.', 'investigatorAffiliation': 'University of Utah'}}}}