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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia | SpO2 ≤ 92% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia in the recovery room | SpO2 ≤ 92% | Length of stay in the recovery room, an expected average of 2 hours |
| Incidence of apnea during the procedure | Breath rate ≤6/min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Center of DAX | Dax | France | ||||
| Pole santé ORELIANCE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21304242 | Result | 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. | |
| 19003534 | Result | 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. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| Incidence of hypoxia with SpO2 ≤ 90% | SpO2 ≤ 90% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| Incidence of severe hypoxia | SpO2 ≤ 85% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| Prolonged hypoxia during the procedure | SpO2 ≤ 92% for ≥60 s | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| Severe hypoxia during the procedure | SpO2 ≤ 90% and SpO2 ≤85% | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| 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 |
| 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 |
| Temporal course of SpO2 | Absolute changes in SpO2 | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| 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 |
| 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 |
| 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 |
| Incidence of bradycardia | Heart rate < 50 bpm | Duration of GI endoscopy procedure under sedation, an expected average of 2 hours |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Need of hospitalisation | percentage of ambulatory patients who needed to be hospitalised after the procedure | 24 hours |
| Serious adverse event rate | Percentage of patients experiencing at least one serious adverse event | 24 hours |
| Orléans |
| 45000 |
| France |
| Orleans Hospital Center | Orléans | 45067 | France |
| 16573781 | Result | 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. |
| 2105779 | Result | 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. |
| 2689263 | Result | 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. |
| 33933271 | Derived | 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. |
| 32075842 | Derived | 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. |