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

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Gastrointestinal Endoscopy; Sedation

Treatments: Device: High-flow nasal cannula oxygenation group

Study type: Interventional

Funder types: Other

Identifiers

NCT03829293

CHRO-2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

High-flow nasal cannula oxygenation group

Experimental group

Description:

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)

Treatment:

Device: High-flow nasal cannula oxygenation group

Standard Oxygenation

No Intervention group

Description:

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)