- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445256
Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy
Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study
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.
This 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
-
-
Merkez Mahallesi
-
Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Scheduled for upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation
- Able to undergo post-procedure monitoring in the recovery unit
- Provided written informed consent for participation and data use
Exclusion Criteria:
- Colonoscopy or combined procedures (EGD + colonoscopy)
- Emergency procedures or procedures performed under intensive care conditions
- Requirement for endotracheal intubation, noninvasive ventilation, or advanced airway support during the procedure
- Known severe upper airway anatomical abnormalities, facial deformity, or tracheostomy
- Inability or refusal to provide informed consent
- Incomplete or unavailable recovery-period oxygen saturation monitoring data
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery-Period Respiratory Events
Time Frame: From end of procedure (scope-out) until discharge from recovery unit
|
Occurrence of respiratory events during the recovery period following sedated upper gastrointestinal endoscopy, defined as at least one of the following: SpO₂ <90% lasting ≥10 seconds Requirement for airway maneuver (jaw-thrust, chin-lift, OPA/NPA, mask ventilation) Escalation or re-initiation of supplemental oxygen |
From end of procedure (scope-out) until discharge from recovery unit
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- endoscopy rox index
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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