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High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.

NCT06610461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-07

No results posted yet for this study

Summary

Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation.

This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.

Conditions

  • Hypoxemia During Surgery

Interventions

DEVICE

HFNO-Treatment

The investigated intervention is the application of HFNO throughout a high-risk upper GI-endoscopy. Concentration of oxygen is 100%. Prior to induction, flow rate is set to 20 l/min and increased to 30 l/min if tolerated by the patient. After induction of anesthesia, flow rate is increased to 60 l/min and maintained throughout the anesthesia.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2025-09-12
Completion
2025-09-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610461 on ClinicalTrials.gov