NCT07439822

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Mar 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

February 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 9, 2026

Last Update Submit

February 23, 2026

Conditions

Hypoxemia During Surgery

Keywords

HIGH-FLOW OXYGENSEDATIONHYPOXEMIA

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Sex (Demographic and explanatory factors)

    Periprocedural

  • Age (Demographic and explanatory factors)

    Periprocedural

  • Body mass index (Demographic and explanatory factors)

    Periprocedural

  • Demographic and explanatory factors

    Periprocedural

  • Medical History Demographic and explanatory factors

    Periprocedural

  • +6 more secondary outcomes

Study Arms (2)

Low-flow medical oxygen insufflation

ACTIVE COMPARATOR

Low-flow medical oxygen insufflation

Drug: Low-flow medical oxygen insufflation

High-flow medical oxygen insufflation

EXPERIMENTAL

High-flow medical oxygen insufflation

Drug: High-flow medical oxygen insufflation

Interventions

High-flow medical oxygen insufflationDRUG

High-flow medical oxygen insufflation

High-flow medical oxygen insufflation
Low-flow medical oxygen insufflationDRUG

Low-flow medical oxygen insufflation

Low-flow medical oxygen insufflation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)