NCT07791979

Brief Summary

Hypoxemia is the most common adverse event during propofol sedation for gastrointestinal endoscopy in patients with chronic obstructive pulmonary disease (COPD) due to diminished pulmonary reserve. Although high-flow nasal cannula (HFNC) oxygenation has been shown to effectively reduce hypoxemia during sedated endoscopy in obese patients, its application in COPD patients remains an evidence gap, largely owing to the traditional concern that high-concentration oxygen may suppress respiratory drive and exacerbate CO₂ retention. This study aims to investigate whether HFNC can reduce the incidence of hypoxemia during sedated gastrointestinal endoscopy in patients with COPD.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

August 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 23, 2026

Last Update Submit

August 26, 2026

Conditions

HypoxemiaGastric Cancer (Diagnosis)Chronic Obstructive Pulmonary Disease (COPD)Esophageal Cancer

Keywords

high-flow nasal cannulaHypoxemiaChronic Obstructive Pulmonary DiseaseSedationGastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypoxemia

    75% ≤ SpO2 \< 90% for \<60 s

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcomes (3)

  • The incidence of sub-clinical respiratory depression

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

  • The incidence of severe hypoxemia

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

  • The incidence of other adverse events

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcomes (1)

  • QoR-PACU₂-15 score at PACU discharge

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (1)

High-flow nasal cannula

EXPERIMENTAL

Using high-flow nasal cannula oxygenation

Device: High-flow nasal cannula

Interventions

High-flow nasal cannulaDEVICE

Using high-flow nasal cannula oxygenation

High-flow nasal cannula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Confirmed diagnosis of chronic obstructive pulmonary disease (COPD);
  • Scheduled for elective sedated gastroenteroscopy (gastroscopy, colonoscopy, or combined gastroscopy and colonoscopy);
  • Expected procedure duration ≤45 minutes;
  • Provision of written informed consent by the participant.

You may not qualify if:

  • Patients with absolute contraindications to high-flow therapy, including but not limited to confirmed diagnosis of complete upper airway obstruction, basilar skull fracture or nasal bone fracture, pneumothorax, or pneumomediastinum.;
  • American Society of Anesthesiologists (ASA) Physical Status class ≥ IV;
  • Requirement for planned endotracheal intubation;
  • Existing tracheostomy;
  • Confirmed pregnancy or currently breastfeeding;
  • Known allergy to sedative agents such as propofol;
  • Current participation in another interventional clinical trial;
  • Any other condition deemed by the investigator to make the patient unsuitable for trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

HypoxiaStomach NeoplasmsDiseasePulmonary Disease, Chronic ObstructiveEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesHead and Neck NeoplasmsEsophageal Diseases

Central Study Contacts

Diansan Su

CONTACT

+8618616514088diansansu@yahoo.com

Mingxia Xu

CONTACT

+8613516713435xumingxia@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician,Researcher

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 28, 2026

Study Start

August 29, 2026

Primary Completion (Estimated)

February 23, 2027

Study Completion (Estimated)

February 23, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)