Gastrointestinal Endoscopy, Sedation
Conditions
Keywords
High-flow nasal cannula oxygenation, gastrointestinal endoscopy, upper gasatrointestinal endoscopy, colonoscopy, sedation, hypoxia
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.
Interventions
DEVICEHigh-flow nasal cannula oxygenation group
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)
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxia | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | SpO2 ≤ 92% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| Incidence of severe hypoxia | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | SpO2 ≤ 85% |
| Prolonged hypoxia during the procedure | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | SpO2 ≤ 92% for ≥60 s |
| Severe hypoxia during the procedure | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | SpO2 ≤ 90% and 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 SpO2 | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours | Absolute changes in SpO2 |
| 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 |
| Incidence of hypoxia in the recovery room | Length of stay in the recovery room, an expected average of 2 hours | SpO2 ≤ 92% |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed