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NCT Number: NCT03829293

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

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.

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Key information

Conditions

Gastrointestinal Endoscopy Hypoxia Pathological Conditions, Signs and Symptoms Sedation Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Center of DAX, Dax, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow nasal cannula oxygenation group

Device

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)

Primary outcomes

  1. Incidence of hypoxia

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

    SpO2 ≤ 92%

Secondary outcomes

  1. Incidence of hypoxia in the recovery room

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

    SpO2 ≤ 92%

  2. Incidence of apnea during the procedure

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

    Breath rate ≤6/min

  3. Incidence of hypoxia with SpO2 ≤ 90%

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

    SpO2 ≤ 90%

  4. Incidence of severe hypoxia

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

    SpO2 ≤ 85%

  5. Prolonged hypoxia during the procedure

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

    SpO2 ≤ 92% for ≥60 s

  6. Severe hypoxia during the procedure

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

    SpO2 ≤ 90% and SpO2 ≤85%

  7. Modification of oxygenation during the procedure

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

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

  8. The need of intervention by the anesthesia team

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

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

  9. Temporal course of SpO2

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

    Absolute changes in SpO2

  10. Temporal course of respiratory rate

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

    Absolute changes in respiratory rate, in cycles/minutes

  11. Temporal course of heart rate

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

    Absolute changes in heart rate, in bpm

  12. Temporal course of arterial blood pressure

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

    Absolute changes arterial blood pressure, in mmHg

  13. Incidence of bradycardia

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

    Heart rate < 50 bpm

  14. Incidence of need for mechanical respiratory support

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

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

  15. Failure of the endoscopic procedure

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

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

  16. Duration of the endoscopic procedure

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

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

  17. Duration of sedation

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

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

  18. Length of stay in the recovery room

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

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

  19. Need of hospitalisation

    Time frame: 24 hours

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

  20. Serious adverse event rate

    Time frame: 24 hours

    Percentage of patients experiencing at least one serious adverse event

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: ODEPHI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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