High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 380
- Locations
- 3
- Primary Endpoint
- Incidence of hypoxia
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High-flow nasal cannula oxygenation group
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)
Intervention: High-flow nasal cannula oxygenation group (Device)
Standard Oxygenation
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)
Outcomes
Primary Outcomes
Incidence of hypoxia
Time Frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
SpO2 ≤ 92%
Secondary Outcomes
- Length of stay in the recovery room(Length of stay in the recovery room, an expected average of 2 hours)
- Failure of the endoscopic procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Incidence of hypoxia in the recovery room(Length of stay in the recovery room, an expected average of 2 hours)
- Incidence of apnea during the procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Incidence of hypoxia with SpO2 ≤ 90%(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Prolonged hypoxia during the procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Temporal course of SpO2(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Duration of the endoscopic procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Duration of sedation(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Severe hypoxia during the procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Temporal course of heart rate(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Incidence of bradycardia(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Incidence of need for mechanical respiratory support(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Incidence of severe hypoxia(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Modification of oxygenation during the procedure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- The need of intervention by the anesthesia team(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Temporal course of respiratory rate(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Temporal course of arterial blood pressure(Duration of GI endoscopy procedure under sedation, an expected average of 2 hours)
- Need of hospitalisation(24 hours)
- Serious adverse event rate(24 hours)