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

Sedation Clinical Trial

— ODEPHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829293
• Other study ID #: CHRO-2019-01
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: September 9, 2019

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• Sedation

Intervention

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)

Locations

Country	Name	City	State
France	Hospital Center of DAX	DAX
France	Orleans Hospital Center	Orléans
France	Pole santé ORELIANCE	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoxia	SpO2 = 92%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	Incidence of hypoxia in the recovery room	SpO2 = 92%	Length of stay in the recovery room, an expected average of 2 hours
Secondary	Incidence of apnea during the procedure	Breath rate =6/min	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	Incidence of hypoxia with SpO2 = 90%	SpO2 = 90%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	Incidence of severe hypoxia	SpO2 = 85%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	Prolonged hypoxia during the procedure	SpO2 = 92% for =60 s	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	Severe hypoxia during the procedure	SpO2 = 90% and SpO2 =85%	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	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
Secondary	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
Secondary	Temporal course of SpO2	Absolute changes in SpO2	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of bradycardia	Heart rate < 50 bpm	Duration of GI endoscopy procedure under sedation, an expected average of 2 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Need of hospitalisation	percentage of ambulatory patients who needed to be hospitalised after the procedure	24 hours
Secondary	Serious adverse event rate	Percentage of patients experiencing at least one serious adverse event	24 hours