Acute Respiratory Failure With Hypoxia, Oxygen Inhalation Therapy, Prehospital Setting
Conditions
Keywords
Respiratory Insufficiency, Oxygen Inhalation Therapy
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.
Interventions
DEVICEHigh-flow nasal oxygen
oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).
DEVICEStandard oxygen therapy
Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| need of mechanical ventilation | 28 days | cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe hypoxemia | 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. |
| Survival | 28 days | Probability of survival from inclusion to day 28 |
| SpO2 | 1 hour | Time course of SpO2 |
| Respiratory rate | 1 hour | Time course of respiratory rate |
| Heart rate | 1 hour | Time course of heart rate |
| Tracheal intubation | 28 days | Cumulative incidence of tracheal intubation from inclusion to day 28. |
| Hypoxemia | 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. |
| arterial pH | 1 hour | arterial pH (units) measured at hospital arrival |
| arterial PaCO2 | 1 hour | arterial PaCO2 (mmHg) measured at hospital arrival |
| arterial PaO2 | 1 hour | arterial PaO2 (mmHg) measured at hospital arrival |
| Dyspnea | 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. |
| Serious Adverse Events | Day 28 | The number of serious adverse events during the intervention phase of the study |
| Noninvasive ventilation | 28 days | Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28 |
Countries
France
Outcome results
None listed