Prehospital High-Flow Nasal Oxygen Therapy

Acute Respiratory Failure With Hypoxia Clinical Trial

— PRHOXY-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326830
• Other study ID #: CHRO-2017-09
• Secondary ID: 2017-A01922-51CH
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: August 10, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypoxia
• Hypoxia
• Oxygen Inhalation Therapy
• Prehospital Setting
• Respiratory Aspiration
• Respiratory Insufficiency

Intervention

Device:
• High-flow nasal oxygen
oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).
• Standard oxygen therapy
Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag

Locations

Country	Name	City	State
France	CHR d'ORLEANS	Orléans
France	Brigade des Sapeurs Pompiers de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Survival	Probability of survival from inclusion to day 28	28 days
Secondary	SpO2	Time course of SpO2	1 hour
Secondary	Respiratory rate	Time course of respiratory rate	1 hour
Secondary	Heart rate	Time course of heart rate	1 hour
Secondary	Tracheal intubation	Cumulative incidence of tracheal intubation from inclusion to day 28.	28 days
Secondary	Noninvasive ventilation	Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28	28 days
Secondary	arterial pH	arterial pH (units) measured at hospital arrival	1 hour
Secondary	arterial PaCO2	arterial PaCO2 (mmHg) measured at hospital arrival	1 hour
Secondary	arterial PaO2	arterial PaO2 (mmHg) measured at hospital arrival	1 hour
Secondary	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
Secondary	Serious Adverse Events	The number of serious adverse events during the intervention phase of the study	Day 28