NCT03829293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 1, 2019

Last Update Submit

February 4, 2020

Conditions

Gastrointestinal EndoscopySedation

Keywords

High-flow nasal cannula oxygenationgastrointestinal endoscopyupper gasatrointestinal endoscopycolonoscopysedationhypoxia

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoxia

    SpO2 ≤ 92%

    Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

Secondary Outcomes (20)

  • Incidence of hypoxia in the recovery room

    Length of stay in the recovery room, an expected average of 2 hours

  • Incidence of apnea during the procedure

    Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

  • Incidence of hypoxia with SpO2 ≤ 90%

    Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

  • Incidence of severe hypoxia

    Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

  • Prolonged hypoxia during the procedure

    Duration of GI endoscopy procedure under sedation, an expected average of 2 hours

  • +15 more secondary outcomes

Study Arms (2)

High-flow nasal cannula oxygenation group

EXPERIMENTAL

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

Standard Oxygenation

NO INTERVENTION

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)

Interventions

High-flow nasal cannula oxygenation groupDEVICE

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)

High-flow nasal cannula oxygenation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Center of DAX

Dax, France

Location

Pole santé ORELIANCE

Orléans, 45000, France

Location

Orleans Hospital Center

Orléans, 45067, France

Location

Related Publications (7)

  • 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.

    PMID: 21304242RESULT

  • 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.

    PMID: 19003534RESULT

  • 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.

    PMID: 16573781RESULT

  • 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.

    PMID: 2105779RESULT

  • 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.

    PMID: 2689263RESULT

  • 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.

    PMID: 33933271DERIVED

  • 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.

    PMID: 32075842DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mai-Anh NAY, Dr

    CHR Orléans

    STUDY DIRECTOR

  • Willy-Serge MFAM, Dr

    CHR Orléans

    PRINCIPAL INVESTIGATOR

  • Olivier BAERT, Dr

    Pôle Santé Oréliance

    PRINCIPAL INVESTIGATOR

  • Adrien AUVET, Dr

    CH de Dax

    PRINCIPAL INVESTIGATOR

  • Francis REMERAND, Dr

    CHU de Tours - hôpital Trousseau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 4, 2019

Study Start

March 26, 2019

Primary Completion

September 9, 2019

Study Completion

September 9, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)