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

High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Sedation; Gastrointestinal Endoscopy
• Intervention / Treatment: Device: High-flow nasal cannula oxygenation group

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 Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • DAX, France
    • Hospital Center of DAX
  • Orléans, France, 45000
    • Pole santé ORELIANCE
  • Orléans, France, 45067
    • Orleans Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: High-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)
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxia	SpO2 ≤ 92%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxia in the recovery room	SpO2 ≤ 92%	Length of stay in the recovery room, an expected average of 2 hours
Incidence of apnea during the procedure	Breath rate ≤6/min	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Incidence of hypoxia with SpO2 ≤ 90%	SpO2 ≤ 90%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Incidence of severe hypoxia	SpO2 ≤ 85%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Prolonged hypoxia during the procedure	SpO2 ≤ 92% for ≥60 s	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Severe hypoxia during the procedure	SpO2 ≤ 90% and SpO2 ≤85%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Modification of oxygenation during the procedure	Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
The need of intervention by the anesthesia team	Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Temporal course of SpO2	Absolute changes in SpO2	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Temporal course of respiratory rate	Absolute changes in respiratory rate, in cycles/minutes	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Temporal course of heart rate	Absolute changes in heart rate, in bpm	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Temporal course of arterial blood pressure	Absolute changes arterial blood pressure, in mmHg	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Incidence of bradycardia	Heart rate < 50 bpm	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Incidence of need for mechanical respiratory support	noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Failure of the endoscopic procedure	Number of patients in whom the endoscopic procedure has to be stopped and postponed	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Duration of the endoscopic procedure	From insertion of the fiberoptic endoscope to its withdrawal, in minutes	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Duration of sedation	From anaesthesia induction to the awakening of the patient, in minutes	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Length of stay in the recovery room	From admission at to discharge from the recovery room, in minutes	Length of stay in the recovery room, an expected average of 2 hours
Need of hospitalisation	percentage of ambulatory patients who needed to be hospitalised after the procedure	24 hours
Serious adverse event rate	Percentage of patients experiencing at least one serious adverse event	24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Study Director: Mai-Anh NAY, Dr, CHR Orléans; Principal Investigator: Willy-Serge MFAM, Dr, CHR Orléans; Principal Investigator: Olivier BAERT, Dr, Pole santé ORELIANCE; Principal Investigator: Adrien AUVET, Dr, CH de Dax; Principal Investigator: Francis REMERAND, Dr, CHU DE TOURS - Hopital Trousseau

Publications and helpful links

General Publications

• Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.
• Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.
• Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.
• Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4. doi: 10.1136/bmj.300.6717.83. No abstract available.
• Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40. doi: 10.1016/s0016-5107(89)72906-0.
• Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
• Eugene A, Fromont L, Auvet A, Baert O, Mfam WS, Remerand F, Boulain T, Nay MA. High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol. BMJ Open. 2020 Feb 18;10(2):e034701. doi: 10.1136/bmjopen-2019-034701.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy; sedation; hypoxia; gastrointestinal endoscopy; High-flow nasal cannula oxygenation; upper gasatrointestinal endoscopy
• Other Study ID Numbers: CHRO-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No