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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypoxemia During Surgery
• Intervention / Treatment: Drug: Low-flow medical oxygen insufflation; Drug: High-flow medical oxygen insufflation

• Study Type: Interventional
• Enrollment (Estimated): 326
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Valladolid
    • Valladolid, Valladolid, Spain, 47012
      • Hospital Universitario Rio Hortega

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be ≥ 18 years old
• Sign the Informed Consent
• Obesity (BMI ≥ 30 kg/m²)
• ASA III
• Stable pulmonary disease (no hospitalization in the last 6 months)
• Stable heart failure (no hospitalization in the last 6 months)
• Diagnosed or suspected obstructive sleep apnea with a score ≥ 3 on the STOP-Bang scale (APPENDIX II)
• History of sedation-related complications in a previous ESP.

Exclusion Criteria:

• ASA IV patients
• Worsening heart failure at the time of the endoscopy or unstable (hospitalized < 6 months)
• Worsening respiratory disease at the time of the endoscopy or unstable (hospitalized < 6 months)
• Pregnant women
• Use of home oxygen therapy
• Patients with orotracheal intubation
• Tracheostomized patients
• Patients allergic to or unable to use propofol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-flow medical oxygen insufflation	Drug: Low-flow medical oxygen insufflation; Low-flow medical oxygen insufflation
Experimental: High-flow medical oxygen insufflation	Drug: High-flow medical oxygen insufflation; High-flow medical oxygen insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of episodes of hypoxemia	The number of hypoxemia episodes per procedure	Periprocedural
Severity of episode of hypoxemia pO2 value	Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 <80%)	Periprocedural
Duration of episode of hypoxemia (in seconds)	Duration of episode of hypoxemia (in seconds)	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex (Demographic and explanatory factors)	Sex (Demographic and explanatory factors)	Periprocedural
Age (Demographic and explanatory factors)	Age (Demographic and explanatory factors)	Periprocedural
Body mass index (Demographic and explanatory factors)	Body mass index (Demographic and explanatory factors)	Periprocedural
Demographic and explanatory factors	anesthetic risk classification: ASA physical status classification Obstructive Sleep Apnea (OSA) or suspected OSA based on the STOP-Bang questionnaire Chronic respiratory disease Chronic heart disease Chronic use of sedative medications History of prior respiratory complication during an endoscopic sedation procedure (ESP)	Periprocedural
Medical History Demographic and explanatory factors	Medical History Demographic and explanatory factors	Periprocedural
Type of Medication and treatment used (Demographic and explanatory factors)	Type of Medication and treatment used (Demographic and explanatory factors)	Periprocedural
Demographic and explanatory factors	Duration of diagnostic/ therapeutic endoscopic Procedure	Periprocedural
Variable results	value of baseline pO2	Periprocedural
Variable results	Complications and Clinical Events	Periprocedural
Length of stay at recovery room and post-procedure (Variable results)	Length of stay at recovery room and post-procedure	Periprocedural
pO2 value (Variable results)	lowest pO2 value during the procedure	Periprocedural

Collaborators and Investigators

• Sponsor: Outcomes'10

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HIGH-FLOW OXYGEN; SEDATION; HYPOXEMIA
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: ICSCYL-2025-097-OXY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The data will be pseudonymized to ensure privacy and will only be accessible to the research team directly involved in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No