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Status unknownNCT05526339Updated Sep 2, 2022

HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

An interventional study of High-flow nasal oxygenation combined with nasopharyngeal airway and Regular nasal cannula combined with nasopharyngeal airway in Gastric Cancer, Gastric Ulcer and Intestinal Cancer, sponsored by RenJi Hospital. Status unknown at 2 sites in China. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.

02

Conditions studied

  • Gastric Cancer
  • Gastric Ulcer
  • Intestinal Cancer
  • Intestinal Polyps

Keywords

  • High-flow nasal oxygenation
  • Gastrointestinal endoscopy
  • Hypoxia
03

In context

Intestinal Neoplasms

177 studies on the registry are indexed under Intestinal Neoplasms; 20 are open to participants now.

This study's planned enrollment of 600 is above the median of 60 across 114 interventional studies indexed under Intestinal Neoplasms.

Browse Intestinal Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
  2. Age ranging from 19 to 80, both male and female
  3. Obese patients,BMI ≥ 28kg/m\^2
  4. ASA I\~III
  5. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with acute respiratory infection in the last 2 weeks
  2. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
  3. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
  4. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
  5. coagulation disorders or platelets \< 100*10\^9/L
  6. Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets
  7. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
  8. Participated in other clinical trials as a subject within 3 months
  9. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
  10. Emergency procedure
  11. Pregnant or breast-feeding women
  12. Patients having procedures with planned tracheal intubation or laryngeal mask
  13. Investigator considers the patients are inappropriate to participate in this trial
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    High-flow nasal oxygenation combined with nasopharyngeal airway

    High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

    Device: High-flow nasal oxygenation combined with nasopharyngeal airway

  • Active comparator
    Regular nasal cannula combined with nasopharyngeal airway

    Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

    Device: Regular nasal cannula combined with nasopharyngeal airway

Interventions

  • DeviceHigh-flow nasal oxygenation combined with nasopharyngeal airway

    The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.

  • DeviceRegular nasal cannula combined with nasopharyngeal airway

    The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.

06

What researchers measure

Primary outcomes

  1. The incidence of hypoxia

    Hypoxia refers to 75%≤SpO2\<90%,\<60S

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

Secondary outcomes

  1. The incidence of severe hypoxia

    Severe hypoxia refers to SpO2\<75% lasting for any time, or 75%≤SpO2\<90%, ≥60s

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

  2. The incidence of subclinical respiratory depression

    Subclinical respiratory depression refers to 90%≤ SpO2\<95%

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

07

Study locations

2 sites
  • Dushu Lake Hospital Affiliated to Soochow University
    Suzhou, Jiangsu 215000, China
  • Second Hospital Affiliated to Soochow University
    Suzhou, Jiangsu 215000, China
    • Jiang Zhu · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05526339
Lead sponsor
RenJi Hospital
Collaborators
Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Sep 2022 (estimated)
Primary completion
May 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Sep 2, 2022

Study contacts

Diansan Su
Contact
diansansu@yahoo.com
+8618616514088
Lingke Chen
Contact
www.clk@163.com
+8618601795041
Diansan Su
principal investigator · RenJi Hospital

Oversight

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

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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