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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07791979
Enrollment
90
Registered
2026-08-28
Start date
2026-08-29
Completion date
2027-02-23
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEHigh-flow nasal cannula

Using high-flow nasal cannula oxygenation

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hypoxemiaPatients will be followed for the duration of hospital stay, an expected average about 2 hours75% ≤ SpO2 \< 90% for \<60 s

Secondary

MeasureTime frameDescription
The incidence of sub-clinical respiratory depressionPatients will be followed for the duration of hospital stay, an expected average about 2 hours90% ≤ SpO2 \< 95%
The incidence of severe hypoxemiaPatients will be followed for the duration of hospital stay, an expected average about 2 hoursSpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
The incidence of other adverse eventsPatients will be followed for the duration of hospital stay, an expected average about 2 hoursOther adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Countries

China

Contacts

CONTACTDiansan Su
diansansu@yahoo.com+8618616514088
CONTACTMingxia Xu
xumingxia@zju.edu.cn+8613516713435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026