Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:03 AM
Study NCT ID:
NCT07451704
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPI-Guided Monitoring for Oxygen Desaturation in ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Parallel Assignment'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Oxygen Desaturation', 'timeFrame': 'During the ERCP procedure', 'description': 'Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Hypoxemia', 'timeFrame': 'During the ERCP procedure', 'description': 'Occurrence of hypoxemia defined as SpO₂ \\< 90% during the ERCP procedure.'}, {'measure': 'Incidence of Apnea', 'timeFrame': 'During the ERCP procedure', 'description': 'Occurrence of apnea detected by capnography during the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Integrated Pulmonary Index', 'ERCP', 'SEDATİON', 'AİRWAY MANGEMENT', 'CAPNOGRAPHY', 'RESPİRATORY'], 'conditions': ['Respiratory Depression', 'Oxygen Desaturation', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation.', 'detailedDescription': 'Adults undergoing elective ERCP are randomized 1:1 to standard monitoring alone or standard monitoring plus visible IPI (SpO₂, respiratory rate, pulse rate, and EtCO₂). Sedation is standardized (midazolam, fentanyl, ketamine) with a target RASS of -3 and routine supplemental oxygen. Oxygen desaturation (\\>5% decrease in SpO₂ from baseline) during the procedure is the primary outcome. Secondary outcomes include hypoxemia (SpO₂ \\<90%), apnea, bradypnea, and the frequency of airway interventions (verbal-tactile stimulation, jaw-thrust, head-tilt).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years,\n* Scheduled for elective ERCP,\n* ASA physical status I-IV\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* ASA physical status ≥V\n* Pregnancy or suspected pregnancy\n* Known allergy to study sedative agents\n* Obstructive or restrictive pulmonary disease\n* Pre-procedural supplemental oxygen therapy or non-invasive ventilation\n* Predicted difficult airway\n* Pre-procedural systolic blood pressure \\<90 mmHg\n* Pre-procedural heart rate \\<60 beats/min\n* Emergency ERCP'}, 'identificationModule': {'nctId': 'NCT07451704', 'acronym': 'IPITrail', 'briefTitle': 'IPI-Guided Monitoring for Oxygen Desaturation in ERCP', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kocaeli City Hospital'}, 'officialTitle': 'IPI-Guided Monitoring Prevents Oxygen Desaturation During ERCP Under Moderate Sedation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IPI-ERCP-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPI GROUP', 'description': 'Standard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds.', 'interventionNames': ['Diagnostic Test: IPI GROUP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Standard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters.', 'interventionNames': ['Diagnostic Test: CONTROL GROUP']}], 'interventions': [{'name': 'IPI GROUP', 'type': 'DIAGNOSTIC_TEST', 'description': 'Real-time monitoring of SpO₂, respiratory rate, pulse rate, and end-tidal CO₂ using capnography with visible IPI values to guide airway interventions during ERCP under moderate sedation.', 'armGroupLabels': ['IPI GROUP']}, {'name': 'CONTROL GROUP', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine monitoring with ECG, non-invasive blood pressure, and pulse oximetry during ERCP under moderate sedation. IPI values are not displayed to the clinical team.', 'armGroupLabels': ['CONTROL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16100', 'city': 'Bursa', 'state': 'Görükle', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Uludağ University Faculty of Medicine Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merve Gökçe', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Merve Gökçe', 'investigatorAffiliation': 'Kocaeli City Hospital'}}}}