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 (ENDOALF-TR)

NCT07439822 Phase 4 ENROLLING_BY_INVITATION

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.

Details

Lead sponsor	Outcomes'10
Phase	Phase 4
Status	ENROLLING_BY_INVITATION
Enrolment	326
Start date	2026-03
Completion	2026-10

Conditions

• Hypoxemia During Surgery

Interventions

• High-flow medical oxygen insufflation
• Low-flow medical oxygen insufflation

Primary outcomes

• Number of episodes of hypoxemia — Periprocedural
  The number of hypoxemia episodes per procedure
• Severity of episode of hypoxemia pO2 value — Periprocedural
  Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 \<80%)
• Duration of episode of hypoxemia (in seconds) — Periprocedural
  Duration of episode of hypoxemia (in seconds)

Countries

Spain