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Not yet recruiting NCT07445256

Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy

Observational Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sedated Upper Gastrointestinal Endoscopy.
Who it may be relevant to
Registry conditions: Hypoxemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study

Overview

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.

Interventions

  • Other Sedated Upper Gastrointestinal Endoscopy
    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.

Primary outcome measures

  • Recovery-Period Respiratory Events [Time frame: From end of procedure (scope-out) until discharge from recovery unit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

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. PMID 32152344
  • 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

Identifiers

NCT: NCT07445256 · endoscopy rox index

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗