ClinicalTrials.gg
RecruitingNCT04500392Updated Jan 11, 2024

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

An interventional study of High-flow nasal cannula oxygenation and Regular nasal cannula in Hypoxia, Gastric Cancer and Esophagus Cancer, sponsored by RenJi Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-11.

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

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Hypoxia by RenJi Hospital — 5 open to participants now, 5 under way, none of them phase 3. Hypoxia · RenJi Hospital.

Planned enrollment
7th of 14
1,000 · median 980
Started
2021
with 3 others
No phase
14 of 14
5 open now
Registered
4th of 14
by date

Among the 14 studies in Hypoxia by RenJi Hospital, this one is the 7th largest by planned enrollment, is one of 4 that started in 2021, is one of 14 with no phase, and was the 4th registered.

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

Browse Hypoxia studies →

Open to participants now

5 of the 14 studies in Hypoxia by RenJi Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 125 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 45 (36%) stop at 75 or younger; 15 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Hypoxia by RenJi Hospital, or all of them as a file.
02

Study summary

Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.

03

Conditions studied

  • Hypoxia
  • Gastric Cancer
  • Esophagus Cancer
  • Polyp of Colon
  • Colon Cancer

Keywords

  • Hypoxia
  • Gastrointestinal endoscopes
  • High-flow nasal cannula Oxygenation
04

Who can participate

Ages eligible
18 Years to 70 Years
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

  • patients undergoing gastrointestinal endoscopes
  • age≥18 years old and ≤70 years old
  • patients or family members signed form
  • I-II
  • ≥ 28kg/m²

Exclusion criteria

Exclusion Criteria:

  • Coagulation disorders or a tendency of nose bleeding;
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
  • Severe aortic stenosis or mitral stenosis;
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
  • Acute myocardial infarction in the last 6 months;
  • Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
  • Diagnosed or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
  • Increased intracranial pressure;
  • Ⅲ-Ⅳ ;
  • Mouth, nose, or throat infection;
  • Liver and kidney disease
  • Fever, defined as core body temperature > 37.5℃;
  • Pregnancy, breastfeeding or positive pregnancy test;
  • Emergency procedure;
  • Patients or family members refused to participate
  • Mental disorders and people without civil capacity
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Control group

    Oxygen(up to 6L/min) supplied with a regular nasal catheter

    Device: Regular nasal cannula

  • Experimental
    High-flow nasal cannula group

    Oxygen(up to 60L/min) supplied with high-flow nasal cannula

    Device: High-flow nasal cannula oxygenation

Interventions

  • DeviceHigh-flow nasal cannula oxygenation

    Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min

  • DeviceRegular nasal cannula

    Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min

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 of 2 hours]

Secondary outcomes

  1. The incidence of subclinical respiratory depression

    (90% ≤ SpO2 \< 95%)

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

  2. The incidence of severe hypoxia

    (SpO2 \< 75% for any duration or 75% \< SpO2 \< 90% for \>/=60 s)

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

  3. Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.

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

07

Study locations

3 of 3 sites recruiting
08

Timeline

Tracking 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

Started May 2021 (actual). Primary completion is estimated for Jan 2024, 32 months after the start.

Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 32 months is above that.

Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.

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

Registered
Aug 2, 2020
First posted
Aug 5, 2020
StartActual
May 6, 2021
Primary completionEst.
Jan 2024
CompletionEst.
Jan 2024
Last update
Jan 11, 2024
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.
No changes since tracking began. The registry record was last updated on Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04500392
Lead sponsor
RenJi Hospital
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Oriental Hospital, Tongji University School of Medicine
Responsible party
diansan su (Vice Chair of the Department of Anesthesiology, RenJi Hospital) — Principal investigator
First posted
Aug 5, 2020
Start date
May 6, 2021
Primary completion
Jan 2024 (estimated)
Completion
Jan 2024 (estimated)
Last update
Jan 11, 2024

Study contacts

Diansan Su, Dr.
Contact
diansansu@yahoo.com
+862168383702
Diansan Su, Dr.
principal investigator · Renji Hospital, Shanghai Jiaotong University, Shanghai, China

Oversight

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

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