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ENROLLING BY INVITATION
NCT07439822
PHASE4

Usefulness of High-flow Oxygen Therapy of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation

Sponsor: Outcomes'10

View on ClinicalTrials.gov

Summary

The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory depression, especially in patients with sleep apnea, obesity, lung diseases, those over 60 years old, or with a history of sedation complications. While preventive measures, such as oxygen administration, are taken, the study aims to compare the effectiveness of new high-flow oxygen therapy devices with conventional nasal cannulas to improve safety during endoscopies.

Official title: Usefulness of High-flow Oxygen Therapy to Improve the Safety of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation: a Randomized Multicenter Comparative Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

326

Start Date

2026-03

Completion Date

2026-10

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

High-flow medical oxygen insufflation

High-flow medical oxygen insufflation

DRUG

Low-flow medical oxygen insufflation

Low-flow medical oxygen insufflation

Locations (1)

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain