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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01922-51 | Other Identifier | IDRCB number issued by the French Government | |
| CHRO-2017-09 | Other Identifier | Study code issued by the sponsor |
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The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days
Patients with respiratory distress and an SpO2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. Need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first SpO2 measured on scene and arrival to the hospital will be the main outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard oxygen therapy | Active Comparator | Standard oxygen therapy will be delivered using any device or combination of devices that are part of usual care: nasal oxygen, and mask with or without a reservoir bag and with or without the Venturi system. The flow will be tapered to target an SpO2 ≥ 95% |
|
| High-flow nasal oxygen (HFNO) | Experimental | Experimental: High-flow nasal oxygen (HFNO) group Device that delivers humidified and warmed high-flow oxygen at flows between 30-60L/min HFNO will be initiated at a flow rate between 30-60 L/min and FiO2 titrated for a target of SpO2 ≥ 95%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal oxygen | Device | oxygen therapy will be delivered through a dedicated system, the Airvo2â„¢ (Fisher&Paykel, New-Zealand). |
|
| Measure | Description | Time Frame |
|---|---|---|
| need of mechanical ventilation | cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Frequency of hypoxemia, defined as sustained (at least 5 min) SpO2 below 90% (SpO2 will be continuously recorded throughout the prehospital medical care period) from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. | 1 hour |
| Severe hypoxemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Anh Nay, MD | Centre Hospitalier Régional d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR d'ORLEANS | Orléans | France | ||||
| Brigade des Sapeurs Pompiers de Paris |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24842506 | Background | Prekker ME, Feemster LC, Hough CL, Carlbom D, Crothers K, Au DH, Rea TD, Seymour CW. The epidemiology and outcome of prehospital respiratory distress. Acad Emerg Med. 2014 May;21(5):543-50. doi: 10.1111/acem.12380. | |
| 27658711 | Background | Kelly AM, Holdgate A, Keijzers G, Klim S, Graham CA, Craig S, Kuan WS, Jones P, Lawoko C, Laribi S; AANZDEM study group. Epidemiology, prehospital care and outcomes of patients arriving by ambulance with dyspnoea: an observational study. Scand J Trauma Resusc Emerg Med. 2016 Sep 22;24(1):113. doi: 10.1186/s13049-016-0305-5. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Bi-center, open-label, parallel, randomized trial with 1:2 allocation ratio (2 patients assigned to standard oxygen therapy for 1 patient assigned to High Flow Nasal Oxygen therapy)
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| Standard oxygen therapy | Device | Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag |
|
Frequency of severe hypoxemia, defined as sustained (at least 5 min) SpO2 below 85% from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. |
| 1 hour |
| Survival | Probability of survival from inclusion to day 28 | 28 days |
| SpO2 | Time course of SpO2 | 1 hour |
| Respiratory rate | Time course of respiratory rate | 1 hour |
| Heart rate | Time course of heart rate | 1 hour |
| Tracheal intubation | Cumulative incidence of tracheal intubation from inclusion to day 28. | 28 days |
| Noninvasive ventilation | Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28 | 28 days |
| arterial pH | arterial pH (units) measured at hospital arrival | 1 hour |
| arterial PaCO2 | arterial PaCO2 (mmHg) measured at hospital arrival | 1 hour |
| arterial PaO2 | arterial PaO2 (mmHg) measured at hospital arrival | 1 hour |
| Dyspnea | Dyspnea intensity as assessed by the patient him/herself at hospital arrival using the following dyspnea score: frank improvement: +2; mild improvement: +1; No change: 0; slight worsening: -1; frank worsening:-2. | 1 hour |
| Serious Adverse Events | The number of serious adverse events during the intervention phase of the study | Day 28 |
| Paris |
| France |
| 17522399 | Background | Stiell IG, Spaite DW, Field B, Nesbitt LP, Munkley D, Maloney J, Dreyer J, Toohey LL, Campeau T, Dagnone E, Lyver M, Wells GA; OPALS Study Group. Advanced life support for out-of-hospital respiratory distress. N Engl J Med. 2007 May 24;356(21):2156-64. doi: 10.1056/NEJMoa060334. |
| 8904594 | Background | Fontanari P, Burnet H, Zattara-Hartmann MC, Jammes Y. Changes in airway resistance induced by nasal inhalation of cold dry, dry, or moist air in normal individuals. J Appl Physiol (1985). 1996 Oct;81(4):1739-43. doi: 10.1152/jappl.1996.81.4.1739. |
| 18540928 | Background | Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6. |
| 32299867 | Background | Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May. |
| 32838373 | Background | Leonard S, Strasser W, Whittle JS, Volakis LI, DeBellis RJ, Prichard R, Atwood CW Jr, Dungan GC 2nd. Reducing aerosol dispersion by high flow therapy in COVID-19: High resolution computational fluid dynamics simulations of particle behavior during high velocity nasal insufflation with a simple surgical mask. J Am Coll Emerg Physicians Open. 2020 Jun 11;1(4):578-591. doi: 10.1002/emp2.12158. eCollection 2020 Aug. |