Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-22 @ 1:00 AM
Study NCT ID:
NCT07445256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery-Period Respiratory Events', 'timeFrame': 'From end of procedure (scope-out) until discharge from recovery unit', 'description': 'Occurrence of respiratory events during the recovery period following sedated upper gastrointestinal endoscopy, defined as at least one of the following:\n\nSpO₂ \\<90% lasting ≥10 seconds\n\nRequirement for airway maneuver (jaw-thrust, chin-lift, OPA/NPA, mask ventilation)\n\nEscalation or re-initiation of supplemental oxygen'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '32152344', 'type': 'RESULT', 'citation': 'Shirota Y, Hirase Y, Suda T, Miyazawa M, Hodo Y, Wakabayashi T. More than half of hypoxemia cases occurred during the recovery period after completion of esophagogastroduodenoscopy with planned moderate sedation. Sci Rep. 2020 Mar 9;10(1):4312. doi: 10.1038/s41598-020-61120-0.'}, {'pmid': '36624087', 'type': 'RESULT', 'citation': 'Pozin IE, Zabida A, Nadler M, Zahavi G, Orkin D, Berkenstadt H. Respiratory complications during recovery from gastrointestinal endoscopies performed by gastroenterologists under moderate sedation. Clin Endosc. 2023 Mar;56(2):188-193. doi: 10.5946/ce.2022.033. Epub 2023 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'Sedation during upper gastrointestinal endoscopy may lead to respiratory events not only during the procedure but also in the early recovery period. Although most hypoxemic episodes are considered transient, their frequency, duration, and clinical consequences during recovery remain insufficiently defined.\n\nThis prospective observational study aims to evaluate the incidence, duration, and clinical impact of recovery-period hypoxemia following sedated upper gastrointestinal endoscopy. Hypoxemia is defined as SpO₂ \\<90% lasting ≥10 seconds. Associated respiratory events and potential risk factors will be analyzed without altering routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation at a single tertiary care endoscopy unit. Participants will be enrolled consecutively and followed prospectively during the immediate recovery period without alteration of routine clinical management.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Scheduled for upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation\n* Able to undergo post-procedure monitoring in the recovery unit\n* Provided written informed consent for participation and data use\n\nExclusion Criteria:\n\n* Colonoscopy or combined procedures (EGD + colonoscopy)\n* Emergency procedures or procedures performed under intensive care conditions\n* Requirement for endotracheal intubation, noninvasive ventilation, or advanced airway support during the procedure\n* Known severe upper airway anatomical abnormalities, facial deformity, or tracheostomy\n* Inability or refusal to provide informed consent\n* Incomplete or unavailable recovery-period oxygen saturation monitoring data'}, 'identificationModule': {'nctId': 'NCT07445256', 'briefTitle': 'Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'endoscopy rox index'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sedated Upper Gastrointestinal Endoscopy', 'type': 'OTHER', 'description': 'Routine upper gastrointestinal endoscopy performed under anesthesiologist-administered sedation. No experimental intervention is applied; the study prospectively observes respiratory events during the recovery period as part of standard clinical care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'state': 'Merkez Mahallesi', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye Üniversity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Istinye University'}}}}