Status:
COMPLETED
High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation.
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
Gastrointestinal Endoscopy
Sedation
Eligibility:
All Genders
18+ years
Phase:
NA
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 gastroin...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT03829293
Start Date
March 26 2019
End Date
September 9 2019
Last Update
February 5 2020
Active Locations (3)
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1
Hospital Center of DAX
Dax, France
2
Pole santé ORELIANCE
Orléans, France, 45000
3
Orleans Hospital Center
Orléans, France, 45067