Clinical trial NCT03829293: High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation.
Official title: High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Endoscopy
Sedation
Keywords: High-flow nasal cannula oxygenation
gastrointestinal endoscopy
upper gasatrointestinal endoscopy
colonoscopy
sedation
hypoxia
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypoxia
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary outcomes:
measure: Incidence of hypoxia in the recovery room
timeFrame: Length of stay in the recovery room, an expected average of 2 hours
measure: Incidence of apnea during the procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Incidence of hypoxia with SpO2 ≤ 90%
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Incidence of severe hypoxia
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Prolonged hypoxia during the procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Severe hypoxia during the procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Modification of oxygenation during the procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: The need of intervention by the anesthesia team
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Temporal course of SpO2
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Temporal course of respiratory rate
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Temporal course of heart rate
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Temporal course of arterial blood pressure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Incidence of bradycardia
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Incidence of need for mechanical respiratory support
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Failure of the endoscopic procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Duration of the endoscopic procedure
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Duration of sedation
timeFrame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
measure: Length of stay in the recovery room
timeFrame: Length of stay in the recovery room, an expected average of 2 hours
measure: Need of hospitalisation
timeFrame: 24 hours
measure: Serious adverse event rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: DAX
country: France
facility: Hospital Center of DAX
city: Orléans
country: France
facility: Pole santé ORELIANCE
city: Orléans
country: France
facility: Orleans Hospital Center
Study officials:
affiliation: CHR Orléans
name: Mai-Anh NAY, Dr
role: STUDY_DIRECTOR
affiliation: CHR Orléans
name: Willy-Serge MFAM, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Pôle Santé Oréliance
name: Olivier BAERT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Dax
name: Adrien AUVET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Tours - hôpital Trousseau
name: Francis REMERAND, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.