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Enrolling by invitation NCT07439822

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

Phase IV Interventional Hypoxemia During Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-flow medical oxygen insufflation, Low-flow medical oxygen insufflation.
Who it may be relevant to
Registry conditions: Hypoxemia During Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of episodes of hypoxemia [Time frame: Periprocedural]
  • Severity of episode of hypoxemia pO2 value [Time frame: Periprocedural]
  • Duration of episode of hypoxemia (in seconds) [Time frame: Periprocedural]
Secondary outcome measures (11)
  • Sex (Demographic and explanatory factors) [Time frame: Periprocedural]
  • Age (Demographic and explanatory factors) [Time frame: Periprocedural]
  • Body mass index (Demographic and explanatory factors) [Time frame: Periprocedural]
  • Demographic and explanatory factors [Time frame: Periprocedural]
  • Medical History Demographic and explanatory factors [Time frame: Periprocedural]
  • Type of Medication and treatment used (Demographic and explanatory factors) [Time frame: Periprocedural]
  • Demographic and explanatory factors [Time frame: Periprocedural]
  • Variable results [Time frame: Periprocedural]
  • Variable results [Time frame: Periprocedural]
  • Length of stay at recovery room and post-procedure (Variable results) [Time frame: Periprocedural]
  • pO2 value (Variable results) [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Universitario Río Hortega — Valladolid

Identifiers

NCT: NCT07439822 · ICSCYL-2025-097-OXY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗