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

Phase 4Enrolling By InvitationNCT07439822

Outcomes'10326 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

326

Conditions

Hypoxemia During Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of episodes of hypoxemia

The number of hypoxemia episodes per procedure

Time frame: Periprocedural

Severity of episode of hypoxemia pO2 value

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

Time frame: Periprocedural

Duration of episode of hypoxemia (in seconds)

Time frame: Periprocedural

Secondary Outcomes

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

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)

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

Duration of diagnostic/ therapeutic endoscopic Procedure

Time frame: Periprocedural

Variable results

value of baseline pO2

Time frame: Periprocedural

Variable results

Complications and Clinical Events

Time frame: Periprocedural

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

Length of stay at recovery room and post-procedure

Time frame: Periprocedural

pO2 value (Variable results)

lowest pO2 value during the procedure

Time frame: Periprocedural

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes