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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-flow nasal oxygen
Standard oxygen therapy
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure With Hypoxia focused on measuring Respiratory Insufficiency, Oxygen Inhalation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'ORLEANS
  • Brigade des Sapeurs Pompiers de Paris

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard oxygen therapy

High-flow nasal oxygen (HFNO)

Arm Description

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%

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%.

Outcomes

Primary Outcome Measures

need of mechanical ventilation
cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2017
Last Updated
February 16, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03326830
Brief Title
Prehospital High-Flow Nasal Oxygen Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure With Hypoxia, Oxygen Inhalation Therapy, Prehospital Setting
Keywords
Respiratory Insufficiency, Oxygen Inhalation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard oxygen therapy
Arm Type
Active Comparator
Arm Description
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%
Arm Title
High-flow nasal oxygen (HFNO)
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
High-flow nasal oxygen
Intervention Description
oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).
Intervention Type
Device
Intervention Name(s)
Standard oxygen therapy
Intervention Description
Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag
Primary Outcome Measure Information:
Title
need of mechanical ventilation
Description
cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Hypoxemia
Description
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.
Time Frame
1 hour
Title
Severe hypoxemia
Description
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.
Time Frame
1 hour
Title
Survival
Description
Probability of survival from inclusion to day 28
Time Frame
28 days
Title
SpO2
Description
Time course of SpO2
Time Frame
1 hour
Title
Respiratory rate
Description
Time course of respiratory rate
Time Frame
1 hour
Title
Heart rate
Description
Time course of heart rate
Time Frame
1 hour
Title
Tracheal intubation
Description
Cumulative incidence of tracheal intubation from inclusion to day 28.
Time Frame
28 days
Title
Noninvasive ventilation
Description
Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28
Time Frame
28 days
Title
arterial pH
Description
arterial pH (units) measured at hospital arrival
Time Frame
1 hour
Title
arterial PaCO2
Description
arterial PaCO2 (mmHg) measured at hospital arrival
Time Frame
1 hour
Title
arterial PaO2
Description
arterial PaO2 (mmHg) measured at hospital arrival
Time Frame
1 hour
Title
Dyspnea
Description
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.
Time Frame
1 hour
Title
Serious Adverse Events
Description
The number of serious adverse events during the intervention phase of the study
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Anh Nay, MD
Organizational Affiliation
Centre Hospitalier Régional d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orléans
Country
France
Facility Name
Brigade des Sapeurs Pompiers de Paris
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24842506
Citation
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Results Reference
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PubMed Identifier
27658711
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.
Results Reference
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PubMed Identifier
17522399
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.
Results Reference
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PubMed Identifier
8904594
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.
Results Reference
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PubMed Identifier
18540928
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.
Results Reference
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PubMed Identifier
32299867
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.
Results Reference
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PubMed Identifier
32838373
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.
Results Reference
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Prehospital High-Flow Nasal Oxygen Therapy

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