NCT07439822

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

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Outcomes'10 · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxemia During Surgery

Interventions

Type	Name	Description
DRUG	High-flow medical oxygen insufflation	High-flow medical oxygen insufflation
DRUG	Low-flow medical oxygen insufflation	Low-flow medical oxygen insufflation

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Spain