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Not yet recruitingNCT07791979Updated Aug 28, 2026

High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease

An interventional study of High-flow nasal cannula in Hypoxemia, Gastric Cancer (Diagnosis) and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Zhejiang University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypoxemia
  • Gastric Cancer (Diagnosis)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Esophageal Cancer

Keywords

  • high-flow nasal cannula
  • Hypoxemia
  • Chronic Obstructive Pulmonary Disease
  • Sedation
  • Gastrointestinal Endoscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    High-flow nasal cannula

    Using high-flow nasal cannula oxygenation

    Device: High-flow nasal cannula

Interventions

  • DeviceHigh-flow nasal cannula

    Using high-flow nasal cannula oxygenation

05

What researchers measure

Primary outcomes

  1. The incidence of hypoxemia

    75% ≤ SpO2 \< 90% for \<60 s

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

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    90% ≤ SpO2 \< 95%

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

  2. The incidence of severe hypoxemia

    SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s

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

  3. The incidence of other adverse events

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

    Time frame: 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

    QoR-PACU₂-15 assessed at PACU discharge to evaluate early recovery quality (15 items, each scored 0-5; total score 0-75, higher scores indicate better recovery).

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

06

Study locations

1 site
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07791979
Lead sponsor
Zhejiang University
Responsible party
Diansan Su (Chief Physician,Researcher, Zhejiang University) — Principal investigator
First posted
Aug 28, 2026
Start date
Aug 29, 2026 (estimated)
Primary completion
Feb 23, 2027 (estimated)
Completion
Feb 23, 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Diansan Su
Contact
diansansu@yahoo.com
+8618616514088
Mingxia Xu
Contact
xumingxia@zju.edu.cn
+8613516713435

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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