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Acute Respiratory Failure With HypoxiaPRHOXY-1NCT03326830

Prehospital High-Flow Nasal Oxygen Therapy

A study testing High-flow nasal oxygen and Standard oxygen therapy in people with Acute Respiratory Failure With Hypoxia and Oxygen Inhalation Therapy, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High-flow nasal oxygen and Standard oxygen therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
2 sitesFrance
Study dates
21 Dec 2017to 10 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHR d'ORLEANS

    Orléans

  • Brigade des Sapeurs Pompiers de Paris

    Paris

Other trials in France

About this study

Official title: 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

Read the 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.

Being tested
High-flow nasal oxygen, Standard oxygen therapy
Keywords
Respiratory Insufficiency, Oxygen Inhalation Therapy
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-flow nasal oxygenDevice

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

  • Standard oxygen therapyDevice

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

Study groups in NCT03326830
Study groupRoleWhat they receive
Standard oxygen therapyActive comparatorStandard 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%
Receives: Device: Standard oxygen therapy
High-flow nasal oxygen (HFNO)ExperimentalExperimental: 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%.
Receives: Device: High-flow nasal oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. need of mechanical ventilation

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

    Measured: 28 days

Secondary outcomes (13)

  1. 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.

    Measured: 1 hour

  2. 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.

    Measured: 1 hour

  3. Survival

    Probability of survival from inclusion to day 28

    Measured: 28 days

  4. SpO2

    Time course of SpO2

    Measured: 1 hour

  5. Respiratory rate

    Time course of respiratory rate

    Measured: 1 hour

  6. Heart rate

    Time course of heart rate

    Measured: 1 hour

  7. Tracheal intubation

    Cumulative incidence of tracheal intubation from inclusion to day 28.

    Measured: 28 days

  8. Noninvasive ventilation

    Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28

    Measured: 28 days

  9. arterial pH

    arterial pH (units) measured at hospital arrival

    Measured: 1 hour

  10. arterial PaCO2

    arterial PaCO2 (mmHg) measured at hospital arrival

    Measured: 1 hour

  11. arterial PaO2

    arterial PaO2 (mmHg) measured at hospital arrival

    Measured: 1 hour

  12. 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.

    Measured: 1 hour

  13. Serious Adverse Events

    The number of serious adverse events during the intervention phase of the study

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2017
  2. Study start21 Dec 2017
  3. Primary completion10 Aug 2022
  4. Study completion10 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03326830
Sponsor's protocol ID
CHRO-2017-09
Other IDs
2017-A01922-51, CHRO-2017-09
Acronym
PRHOXY-1
Status last verified
Feb 2023
First submitted
27 Oct 2017
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24842506

  • 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.

    PubMed 27658711

  • 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.

    PubMed 17522399

  • 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.

    PubMed 8904594

  • 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.

    PubMed 18540928

  • 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.

    PubMed 32299867

  • 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.

    PubMed 32838373

Questions about this trial

What is this clinical trial studying?

A study testing High-flow nasal oxygen and Standard oxygen therapy in people with Acute Respiratory Failure With Hypoxia and Oxygen Inhalation Therapy, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

need of mechanical ventilation (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326830, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

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