Prehospital High-Flow Nasal Oxygen Therapy

Not Applicable

Completed

Conditions: Acute Respiratory Failure With Hypoxia
Prehospital Setting
Oxygen Inhalation Therapy

Interventions: Device: Standard oxygen therapy
Device: High-flow nasal oxygen

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard oxygen therapy	Standard oxygen therapy	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%
High-flow nasal oxygen (HFNO)	High-flow nasal oxygen	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%.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
arterial PaO2	1 hour	arterial PaO2 (mmHg) measured at hospital arrival
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.
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.
Noninvasive ventilation	28 days	Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28
arterial pH	1 hour	arterial pH (units) measured at hospital arrival
arterial PaCO2	1 hour	arterial PaCO2 (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

Locations (2): CHR d'ORLEANS
🇫🇷
Orléans, France
Brigade des Sapeurs Pompiers de Paris
🇫🇷
Paris, France