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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study

Conditions
-----------------
Gastrointestinal Endoscopy, Sedation

Intervention / Treatment
-----------------
* Device: High-flow nasal cannula oxygenation group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal cannula oxygenation group<br>Participants in the experimental group will receive high-flow nasal oxygen therapy (HFNO) during gastrointestinal endoscopy under sedation (with a flow at 70L/min and oxygen inspired fraction (FiO2) 50%) through a dedicated system, the THRIVETM (Fisher&Paykel, New-Zealand) | Device: High-flow nasal cannula oxygenation group<br>* 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)<br>|
| No Intervention: Standard Oxygenation<br>Participants in the current standard of care will receive standard oxygenation by nasal prongs (with a flow at 6L/min) or naropharyngeal catheter (with a flow at 5L/min) or standard face mask (with a flow at 6L/min) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia | SpO2 ≤ 92% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia in the recovery room | SpO2 ≤ 92% | Length of stay in the recovery room, an expected average of 2 hours | 
| Incidence of apnea during the procedure | Breath rate ≤6/min | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Incidence of hypoxia with SpO2 ≤ 90% | SpO2 ≤ 90% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Incidence of severe hypoxia | SpO2 ≤ 85% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Prolonged hypoxia during the procedure | SpO2 ≤ 92% for ≥60 s | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Severe hypoxia during the procedure | SpO2 ≤ 90% and SpO2 ≤85% | 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 | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| The need of intervention by the anesthesia team | Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Temporal course of SpO2 | Absolute changes in SpO2 | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Temporal course of respiratory rate | Absolute changes in respiratory rate, in cycles/minutes | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Temporal course of heart rate | Absolute changes in heart rate, in bpm | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Temporal course of arterial blood pressure | Absolute changes arterial blood pressure, in mmHg | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Incidence of bradycardia | Heart rate < 50 bpm | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Incidence of need for mechanical respiratory support | noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Failure of the endoscopic procedure | Number of patients in whom the endoscopic procedure has to be stopped and postponed | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Duration of the endoscopic procedure | From insertion of the fiberoptic endoscope to its withdrawal, in minutes | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Duration of sedation | From anaesthesia induction to the awakening of the patient, in minutes | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | 
| Length of stay in the recovery room | From admission at to discharge from the recovery room, in minutes | Length of stay in the recovery room, an expected average of 2 hours | 
| Need of hospitalisation | percentage of ambulatory patients who needed to be hospitalised after the procedure | 24 hours | 
| Serious adverse event rate | Percentage of patients experiencing at least one serious adverse event | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-flow nasal cannula oxygenation, gastrointestinal endoscopy, upper gasatrointestinal endoscopy, colonoscopy, sedation, hypoxia