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Gastrointestinal EndoscopyODEPHINCT03829293

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

A study testing High-flow nasal cannula oxygenation group in people with Gastrointestinal Endoscopy and Sedation, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Endoscopy, Sedation
What is being tested?
High-flow nasal cannula oxygenation group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
3 sitesFrance
Study dates
26 Mar 2019to 9 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

France3 sites

  • Hospital Center of DAX

    Dax

  • Pole santé ORELIANCE

    Orléans, 45000

  • Orleans Hospital Center

    Orléans, 45067

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
High-flow nasal cannula oxygenation group
Keywords
High-flow nasal cannula oxygenation, gastrointestinal endoscopy, upper gasatrointestinal endoscopy, colonoscopy, sedation, hypoxia
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT03829293
Study groupRoleWhat they receive
High-flow nasal cannula oxygenation groupExperimentalParticipants 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)
Receives: Device: High-flow nasal cannula oxygenation group
Standard OxygenationNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hypoxia

    SpO2 ≤ 92%

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

Secondary outcomes (20)

  1. Incidence of hypoxia in the recovery room

    SpO2 ≤ 92%

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

  2. Incidence of apnea during the procedure

    Breath rate ≤6/min

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

  3. Incidence of hypoxia with SpO2 ≤ 90%

    SpO2 ≤ 90%

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

  4. Incidence of severe hypoxia

    SpO2 ≤ 85%

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

  5. Prolonged hypoxia during the procedure

    SpO2 ≤ 92% for ≥60 s

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

  6. Severe hypoxia during the procedure

    SpO2 ≤ 90% and SpO2 ≤85%

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

  7. Modification of oxygenation during the procedure

    Increase of oxygen flow in conventional group or FiO2 in the interventional group to maintain an adequate oxygenation

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

  8. The need of intervention by the anesthesia team

    Need of airway manipulation, use of noninvasive ventilation or mechanical invasive ventilation

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

  9. Temporal course of SpO2

    Absolute changes in SpO2

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

  10. Temporal course of respiratory rate

    Absolute changes in respiratory rate, in cycles/minutes

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

  11. Temporal course of heart rate

    Absolute changes in heart rate, in bpm

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

  12. Temporal course of arterial blood pressure

    Absolute changes arterial blood pressure, in mmHg

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

  13. Incidence of bradycardia

    Heart rate < 50 bpm

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

  14. Incidence of need for mechanical respiratory support

    noninvasive ventilation, or ventilation through a laryngeal mask, or tracheal intubation

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

  15. Failure of the endoscopic procedure

    Number of patients in whom the endoscopic procedure has to be stopped and postponed

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

  16. Duration of the endoscopic procedure

    From insertion of the fiberoptic endoscope to its withdrawal, in minutes

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

  17. Duration of sedation

    From anaesthesia induction to the awakening of the patient, in minutes

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

  18. Length of stay in the recovery room

    From admission at to discharge from the recovery room, in minutes

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

  19. Need of hospitalisation

    percentage of ambulatory patients who needed to be hospitalised after the procedure

    Measured: 24 hours

  20. Serious adverse event rate

    Percentage of patients experiencing at least one serious adverse event

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start26 Mar 2019
  3. Primary completion9 Sep 2019
  4. Study completion9 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829293
Sponsor's protocol ID
CHRO-2019-01
Acronym
ODEPHI
Status last verified
Feb 2020
First submitted
1 Feb 2019
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21304242

  • 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.

    PubMed 19003534

  • 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.

    PubMed 16573781

  • 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.

    PubMed 2105779

  • 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.

    PubMed 2689263

  • 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.

    PubMed 33933271

  • 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.

    PubMed 32075842

Questions about this trial

What is this clinical trial studying?

A study testing High-flow nasal cannula oxygenation group in people with Gastrointestinal Endoscopy and Sedation, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hypoxia (time frame: Duration of GI endoscopy procedure under sedation, an expected average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03829293, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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