Clinical trial NCT03326830: Prehospital High-Flow Nasal Oxygen Therapy
Official title: Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure With Hypoxia
Oxygen Inhalation Therapy
Prehospital Setting
Keywords: Respiratory Insufficiency
Oxygen Inhalation Therapy
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* First SpO2 on scene \<90%
* At least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate ≥ 25/min; (b) laboured breathing
* No advance directives or known decisions of Do Not intubate or Do Not Ventilate order.

Exclusion Criteria:

* Known COPD or other hypercapnic chronic respiratory failure
* age \<18 years
* Pregnancy or breastfeeding
* Anatomical factors precluding the use of a nasal cannula
* Emergency intubation required
* Patients with tracheostomy
* Patient transported to a hospital not involved in the study

Primary outcomes:
measure: need of mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Hypoxemia
timeFrame: 1 hour
measure: Severe hypoxemia
timeFrame: 1 hour
measure: Survival
timeFrame: 28 days
measure: SpO2
timeFrame: 1 hour
measure: Respiratory rate
timeFrame: 1 hour
measure: Heart rate
timeFrame: 1 hour
measure: Tracheal intubation
timeFrame: 28 days
measure: Noninvasive ventilation
timeFrame: 28 days
measure: arterial pH
timeFrame: 1 hour
measure: arterial PaCO2
timeFrame: 1 hour
measure: arterial PaO2
timeFrame: 1 hour
measure: Dyspnea
timeFrame: 1 hour
measure: Serious Adverse Events
timeFrame: Day 28
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'ORLEANS
city: Paris
country: France
facility: Brigade des Sapeurs Pompiers de Paris
Study officials:
affiliation: Centre Hospitalier Régional d'Orléans
name: Mai-Anh Nay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.