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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • High-flow nasal cannula

    Device

    Using high-flow nasal cannula oxygenation

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: High-flow nasal cannulaExperimental treatment 1 intervention

Trial outcomes

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

Sponsors and contacts

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