Prehospital High-Flow Nasal Oxygen Therapy

NCT03326830 | Completed

• 2 other identifiers: CHRO-2017-092017-A01922-51
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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

Conditions

Acute Respiratory Failure With Hypoxia; Oxygen Inhalation Therapy; Prehospital Setting

Keywords

Respiratory Insufficiency; Oxygen Inhalation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Hypoxemia

  1 hour

• Severe hypoxemia

  1 hour

• Survival

  28 days

• SpO2

  1 hour

• Respiratory rate

  1 hour

Study Arms (2)

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%

Device: Standard oxygen therapy

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%.

Device: High-flow nasal oxygen

Interventions

High-flow nasal oxygen DEVICE

oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher\&Paykel, New-Zealand).

High-flow nasal oxygen (HFNO)

Standard oxygen therapy DEVICE

Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag

Standard oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (2)

CHR d'ORLEANS

Orléans, France

Location

Brigade des Sapeurs Pompiers de Paris

Paris, France

Location

Related Publications (7)

• 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.

  PMID: 24842506 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.

  PMID: 27658711 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.

  PMID: 17522399 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.

  PMID: 8904594 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.

  PMID: 18540928 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.

  PMID: 32299867 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.

  PMID: 32838373 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mai-Anh Nay, MD

  Centre Hospitalier Régional d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: December 21, 2017
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)