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NCT Number: NCT03326830

Prehospital High-Flow Nasal Oxygen Therapy

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

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Key information

Conditions

Acute Respiratory Failure With Hypoxia Oxygen Inhalation Therapy Prehospital Setting Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'ORLEANS, Orléans, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow nasal oxygen

Device

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

Standard oxygen therapy

Device

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

Primary outcomes

  1. need of mechanical ventilation

    Time frame: 28 days

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

Secondary outcomes

  1. Hypoxemia

    Time frame: 1 hour

    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.

  2. Severe hypoxemia

    Time frame: 1 hour

    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.

  3. Survival

    Time frame: 28 days

    Probability of survival from inclusion to day 28

  4. SpO2

    Time frame: 1 hour

    Time course of SpO2

  5. Respiratory rate

    Time frame: 1 hour

    Time course of respiratory rate

  6. Heart rate

    Time frame: 1 hour

    Time course of heart rate

  7. Tracheal intubation

    Time frame: 28 days

    Cumulative incidence of tracheal intubation from inclusion to day 28.

  8. Noninvasive ventilation

    Time frame: 28 days

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

  9. arterial pH

    Time frame: 1 hour

    arterial pH (units) measured at hospital arrival

  10. arterial PaCO2

    Time frame: 1 hour

    arterial PaCO2 (mmHg) measured at hospital arrival

  11. arterial PaO2

    Time frame: 1 hour

    arterial PaO2 (mmHg) measured at hospital arrival

  12. Dyspnea

    Time frame: 1 hour

    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.

  13. Serious Adverse Events

    Time frame: Day 28

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: PRHOXY-1

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2017
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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