High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation.

Centre Hospitalier Régional d'Orléans380 enrolled

Overview

This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO) versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask) during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.

Hypoxemia is the most common complication during a gastrointestinal endoscopy with sedation. Oxygenation is usually applied during the procedure to prevent the occurrence of desaturation. Conventional oxygen is typically administered by conventional nasal cannula, by nasopharyngeal catheter or by a facemask with mild flow of oxygen. The flow of standard oxygen is limited to 15L/min. High-flow nasal cannula oxygenation is a new method of humidified and heated oxygenation with a higher flow rates (up to 70L/min). The primary outcome will be the incidence of hypoxia defined by pulsed saturation with oxygen (SpO2) ≤92%. The investigator's hypothesis is that high-flow nasal oxygen therapy will decrease the frequency of hypoxemia during gastrointestinal endoscopy under sedation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

380

Conditions

Gastrointestinal Endoscopy Sedation

Interventions

High-flow nasal cannula oxygenation groupDEVICE

usual care + High-flow nasal oxygenation (HFNO) therapy during GI endoscopy under sedation (with a flow at 70L/min and FiO2 50%) through a dedicated system, the THRIVETM (Fisher\&Paykel, New-Zealand)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than or equal to 18 years * Having GI endoscopy expected under sedation * At risk of hypoxia defined by (one of the item): an underlying cardiac disease ; an underlying respiratory disease ; age greater than or equal to 60 years ; ASA II, III or ASA IV ; with an body mass index greater or equal to 30 (kg/m²); with sleep apnea syndrome diagnosed or suspected with a STOP-BANG score ≥ 3 Exclusion Criteria: * Age below 18 * Emergency GI endoscopy * Need of intubation for the procedure * Patient with chronic oxygen treatment * Patients with tracheostomy * Pregnancy, breastfeeding * Not affiliated to French social security

Locations (3)

Hospital Center of DAX

Dax, France

Pole santé ORELIANCE

Orléans, France

Orleans Hospital Center

Orléans, France

Outcomes

Primary Outcomes

Incidence of hypoxia

SpO2 ≤ 92%

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Secondary Outcomes

Incidence of hypoxia in the recovery room

SpO2 ≤ 92%

Time frame: Length of stay in the recovery room, an expected average of 2 hours

Incidence of apnea during the procedure

Breath rate ≤6/min

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Incidence of hypoxia with SpO2 ≤ 90%

SpO2 ≤ 90%

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Incidence of severe hypoxia

SpO2 ≤ 85%

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Prolonged hypoxia during the procedure

SpO2 ≤ 92% for ≥60 s

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Severe hypoxia during the procedure

SpO2 ≤ 90% and SpO2 ≤85%

Time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Modification of oxygenation during the procedure

Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation

Data from ClinicalTrials.gov

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