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Not yet recruitingNCT07904260Updated Oct 29, 2026

Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions

An interventional study of High-flow nasal cannula Group and Regular Nasal Cannula Group in Hypoxemia, Gastric Cancer (Diagnosis) and Esophageal Cancer, sponsored by Diansan Su. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Diansan Su · Not applicable, Interventional, and Prevention

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients living in high-altitude areas naturally have lower blood oxygen levels. Those at high risk for Obstructive Sleep Apnea (OSA) face an even greater risk of low oxygen during painless gastrointestinal endoscopy. This multicenter study will randomly assign these patients to receive either High-Flow Nasal Oxygen (HFNC) or standard oxygen therapy during their procedure, aiming to find out if HFNC can safely and effectively reduce the risk of low oxygen events.

02

Conditions studied

  • Hypoxemia
  • Gastric Cancer (Diagnosis)
  • Esophageal Cancer
  • High-altitude Illness
  • Obstructive Sleep Apnea (OSA)

Keywords

  • Sedation
  • high-flow nasal cannula
  • Hypoxemia
  • Gastrointestinal Endoscopy
  • High-altitude illness
03

In context

Hypoxia

1,248 studies on the registry are indexed under Hypoxia; 239 are open to participants now.

This study's planned enrollment of 430 is above the median of 45 across 864 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Diansan Su is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years.
  • Long-term residence in a high-altitude region (continuous residence in a high-altitude region within the past 1 year).
  • STOP-Bang score ≥5.
  • Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
  • Patients have signed the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Patients with absolute contraindications to high-flow nasal oxygen therapy, including confirmed complete upper airway obstruction, skull base fracture, nasal bone fracture, pneumothorax, or pneumomediastinum.
  • ASA physical status > IV.
  • Planned endotracheal intubation.
  • Prior tracheostomy.
  • Confirmed pregnancy or current breastfeeding.
  • Allergy to sedatives such as propofol.
  • Current participation in another clinical trial.
  • Patients deemed unsuitable for this trial by the investigator.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
430 participants (estimated)

Study arms

  • Experimental
    High-flow nasal cannula Group

    In this group, patients use the High-flow nasal cannula

    Device: High-flow nasal cannula Group

  • Active comparator
    Regular Nasal Cannula Group

    In this group, patients use the regular nasal cannula for oxygenation.

    Device: Regular Nasal Cannula Group

Interventions

  • DeviceHigh-flow nasal cannula Group

    Using High-flow nasal cannula oxygenation

  • DeviceRegular Nasal Cannula Group

    Using regular nasal cannula for oxygenation

06

What researchers measure

Primary outcomes

  1. The incidence of hypoxia

    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 hypoxia

    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

  2. Lowest SpO₂ During the PACU

    The lowest peripheral oxygen saturation (SpO₂) value recorded during the patient's stay in the post-anesthesia care unit (PACU). SpO₂ is continuously monitored by pulse oximetry from the time of arrival in the PACU.

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

07

Study locations

3 sites
  • Haiyan County People's Hospital
    Sanjiaocheng, Qinghai 812200, China
  • Qinghai Provincial Traffic Hospital
    Xining, Qinghai 810000, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.

Of 376 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 408 studies reached it within 13 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2026
First posted
Oct 29, 2026
StartEst.
Nov 2, 2026
Primary completionEst.
Oct 31, 2027
CompletionEst.
Oct 31, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07904260
Lead sponsor
Diansan Su
Responsible party
Diansan Su (Chief Physician,Researcher, Zhejiang University) — Sponsor-investigator
First posted
Oct 29, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Oct 29, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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