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Enrolling by Invitation

NCT Number: NCT07439822

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

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.

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Key information

Conditions

Hypoxemia During Surgery Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Río Hortega

Valladolid, 47012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow medical oxygen insufflation

Drug

High-flow medical oxygen insufflation

Low-flow medical oxygen insufflation

Drug

Low-flow medical oxygen insufflation

Primary outcomes

  1. Number of episodes of hypoxemia

    Time frame: Periprocedural

    The number of hypoxemia episodes per procedure

  2. Severity of episode of hypoxemia pO2 value

    Time frame: Periprocedural

    Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 <80%)

  3. Duration of episode of hypoxemia (in seconds)

    Time frame: Periprocedural

    Duration of episode of hypoxemia (in seconds)

Secondary outcomes

  1. Sex (Demographic and explanatory factors)

    Time frame: Periprocedural

    Sex (Demographic and explanatory factors)

  2. Age (Demographic and explanatory factors)

    Time frame: Periprocedural

    Age (Demographic and explanatory factors)

  3. Body mass index (Demographic and explanatory factors)

    Time frame: Periprocedural

    Body mass index (Demographic and explanatory factors)

  4. Demographic and explanatory factors

    Time frame: Periprocedural

    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)

  5. Medical History Demographic and explanatory factors

    Time frame: Periprocedural

    Medical History Demographic and explanatory factors

  6. Type of Medication and treatment used (Demographic and explanatory factors)

    Time frame: Periprocedural

    Type of Medication and treatment used (Demographic and explanatory factors)

  7. Demographic and explanatory factors

    Time frame: Periprocedural

    Duration of diagnostic/ therapeutic endoscopic Procedure

  8. Variable results

    Time frame: Periprocedural

    value of baseline pO2

  9. Variable results

    Time frame: Periprocedural

    Complications and Clinical Events

  10. Length of stay at recovery room and post-procedure (Variable results)

    Time frame: Periprocedural

    Length of stay at recovery room and post-procedure

  11. pO2 value (Variable results)

    Time frame: Periprocedural

    lowest pO2 value during the procedure

Sponsors and collaborators

Lead sponsor

Outcomes'10

Network

Registry information

Official study 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

Acronym: ENDOALF-TR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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