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NCT Number: NCT07791979

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

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.

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Key information

Conditions

Hypoxemia Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Digestive System Diseases Digestive System Neoplasms Disease Disease Attributes Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer (Diagnosis) Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hypoxia Lung Diseases Lung Diseases, Obstructive Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location contact

Diansan Su

CONTACT

[email protected]

+8618616514088

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

High-flow nasal cannula

Device

Using high-flow nasal cannula oxygenation

Primary outcomes

  1. The incidence of hypoxemia

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

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

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

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxemia

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

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

  3. The incidence of other adverse events

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

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

Other outcomes

  1. QoR-PACU₂-15 score at PACU discharge

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su

CONTACT

[email protected]

+8618616514088

Mingxia Xu

CONTACT

[email protected]

+8613516713435

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease: A Single-Arm Simon Two-Stage Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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