High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation.
- Conditions
- Gastrointestinal EndoscopySedation
- Interventions
- Device: High-flow nasal cannula oxygenation group
- Registration Number
- NCT03829293
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-flow nasal cannula oxygenation group 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)
- Primary Outcome Measures
Name Time Method Incidence of hypoxia Duration of GI endoscopy procedure under sedation, an expected average of 2 hours SpO2 ≤ 92%
- Secondary Outcome Measures
Name Time Method Failure of the endoscopic procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Number of patients in whom the endoscopic procedure has to be stopped and postponed
Duration of sedation Duration of GI endoscopy procedure under sedation, an expected average of 2 hours From anaesthesia induction to the awakening of the patient, in minutes
Incidence of hypoxia in the recovery room Length of stay in the recovery room, an expected average of 2 hours SpO2 ≤ 92%
Incidence of apnea during the procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Breath rate ≤6/min
Incidence of hypoxia with SpO2 ≤ 90% Duration of GI endoscopy procedure under sedation, an expected average of 2 hours SpO2 ≤ 90%
Prolonged hypoxia during the procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours SpO2 ≤ 92% for ≥60 s
Temporal course of SpO2 Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Absolute changes in SpO2
Duration of the endoscopic procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours From insertion of the fiberoptic endoscope to its withdrawal, in minutes
Severe hypoxia during the procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours SpO2 ≤ 90% and SpO2 ≤85%
Temporal course of heart rate Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Absolute changes in heart rate, in bpm
Incidence of bradycardia Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Heart rate \< 50 bpm
Incidence of need for mechanical respiratory support Duration of GI endoscopy procedure under sedation, an expected average of 2 hours noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation
Length of stay in the recovery room Length of stay in the recovery room, an expected average of 2 hours From admission at to discharge from the recovery room, in minutes
Incidence of severe hypoxia Duration of GI endoscopy procedure under sedation, an expected average of 2 hours SpO2 ≤ 85%
Modification of oxygenation during the procedure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation
The need of intervention by the anesthesia team Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation
Temporal course of respiratory rate Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Absolute changes in respiratory rate, in cycles/minutes
Temporal course of arterial blood pressure Duration of GI endoscopy procedure under sedation, an expected average of 2 hours Absolute changes arterial blood pressure, in mmHg
Need of hospitalisation 24 hours percentage of ambulatory patients who needed to be hospitalised after the procedure
Serious adverse event rate 24 hours Percentage of patients experiencing at least one serious adverse event
Trial Locations
- Locations (3)
Hospital Center of DAX
🇫🇷DAX, France
Pole santé ORELIANCE
🇫🇷Orléans, France
Orleans Hospital Center
🇫🇷Orléans, France