Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy

NCT07445256 | Not Yet Recruiting

• 1 other identifier: endoscopy rox index
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Recovery-Period Respiratory Events

  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

Interventions

Sedated Upper Gastrointestinal Endoscopy OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

• 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: 32152344 RESULT

• 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.

  PMID: 36624087 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: February 28, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 20, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

TU (1)