Prehospital High-Flow Nasal Oxygen Therapy (PRHOXY-1)

Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure With Hypoxia; Oxygen Inhalation Therapy; Prehospital Setting
• Intervention / Treatment: Device: Standard oxygen therapy; Device: High-flow nasal oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France
    • CHR d'Orléans
  • Paris, France
    • Brigade des Sapeurs Pompiers de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard oxygen therapy; 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%	Device: Standard oxygen therapy; Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag
Experimental: High-flow nasal oxygen (HFNO); 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%.	Device: High-flow nasal oxygen; oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Mai-Anh Nay, MD, Centre Hospitalier Regional D'Orleans

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory Insufficiency; Oxygen Inhalation Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: CHRO-2017-09 (Other Identifier: Study code issued by the sponsor); 2017-A01922-51 (Other Identifier: IDRCB number issued by the French Government)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No