Skip to content

HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients

High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05510388
Acronym
HRISK
Enrollment
450
Registered
2022-08-22
Start date
2022-09-01
Completion date
2023-06-30
Last updated
2022-08-22

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

Conditions

Gastric Cancer, Gastritis, Intestinal Cancer, Intestine Adenoma

Keywords

Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy

Brief summary

The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.

Interventions

The patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37℃ until the end of procedure.

DEVICERegular nasal cannula oxygenation

The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age ranging from 18 to 80, both sexes 2. Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure 3. ASA Ⅲ\ Ⅳ 4. 18 kg/m2\<BMI\<28kg/m2 5. The anticipated operation time of the procedure shall be less than 30min. 6. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion criteria

1. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula. 2. Patients diagnosed POCD 3. Patients clearly identified difficult airway 4. Patients with mechanical ventilation 5. Patients with acute respiratory infection and asthma 6. Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents 7. Patients with aortic stenosis and carotid stenosis 8. Patients allergic to sedatives such as propofol 9. Patients without civil capacity such as cognitive dysfunction

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hypoxiaPatients will be followed for the duration of hospital stay, an expected average of 2 hoursHypoxia refers to 75%≤SpO2\<90%,\<60S

Secondary

MeasureTime frameDescription
The incidence of severe hypoxiaPatients will be followed for the duration of hospital stay, an expected average of 2 hoursSevere hypoxia refers to SpO2\<75% lasting for any time, or 75%≤SpO2\<90%, ≥60s
The incidence of subclinical respiratory depressionPatients will be followed for the duration of hospital stay, an expected average of 2 hoursSubclinical respiratory depression refers to 90%≤ SpO2\<95%
Other adverse events evaluated by the tool of World SIVAPatients will be followed for the duration of hospital stay, an expected average of 2 hours
Complications related to high-flow nasal cannulaPatients will be followed for the duration of hospital stay, an expected average of 2 hours

Countries

China

Contacts

Primary ContactWanfeng Liu
liuwanfeng@renji.com+8613817793010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026