HFNO or Conventional Oxygen Therapy for Patients With Acute Hypoxemic Respiratory Distress
Efficacy of High Flow Nasal Oxygen Therapy Started in the Emergency Room Versus Conventional Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Distress
Centre Hospitalier Universitaire de Besancon
500 participants
Nov 23, 2020
INTERVENTIONAL
Conditions
Summary
A quarter of the patients admitted to the Shock Room or Resuscitation Room of an Emergency Department (ED) are admitted for severe hypoxemia resulting from acute respiratory distress. Like all life-threatening conditions, acute respiratory distress (ARD) requires a rapid identification and a prompt implementation of effective resuscitation measures. Oxygen treatment, first described in 1890, remains one of the most important discoveries in medicine. The purpose of oxygenation is to alleviate respiratory failure and to restore a satisfactory hematosis. The choice of the oxygen delivery device is based on the severity of the hypoxemia, the underlying physiological problems, the type of dyspnea and the patient's tolerance to the device. The most commonly used devices are nasal cannula, face mask and high-concentration face mask (conventional oxygen therapy). High Flow Nasal Oxygen (HFNO) is now widely used as a complement to conventional oxygen therapy in the EDs. HFNO ensures good clinical tolerance and better patient comfort (humidification and heating of inhaled gases...) than the other oxygen devices. The HFNO flow rate can go up to 60-70 L/min with an FIO2 (fraction of inspired oxygen inspired oxygen fraction) of 100% compared to a maximum output of 15 L/min with conventional oxygen-therapy. Given the lack of data and clinical trials concerning the systematic use of HFNO in EDs in cases of severe hypoxemia, a prospective study is essential. The purpose of this work is to evaluate the contribution of early administration of HFNO for patients with acute non-hypercapnic respiratory distress presenting in the ED, with the aim of obtaining rapid correction of hematosis. The objective of this work is to compare Conventional Oxygen Therapy (CO) delivered by nasal cannula or nasal-oral mask at flow rates up to a maximum of 15 liters, to HFNO with the hypothesis that HFNO would reduce the need for ventilation therapy escalation. The other hypotheses concern the interest of the HFNO in reducing the use of intensive care hospitalization and thus the costs of treating these patients.
Eligibility
Inclusion Criteria6
- Patients over 18 years of age
- Admitted to the Emergency Department for acute respiratory distress :
- Respiratory rate ≥ at 25 cycles/min.
- And SpO2 ≤ at 95% without or with oxygen whatever the mode.
- And clinical signs of respiratory distress (pulling, thoraco-abdominal swinging).
- And PaO2/FIO2 ratio < 300mmHg.
Exclusion Criteria12
- Hypercapnic patients (PaCO2 > 45mmHg) with respiratory acidosis (pH<7.30).
- Indication for non-invasive ventilation or early invasive mechanical ventilation according to current scientific recommendations (acute pulmonary edema, Chronic obstructive pulmonary disease decompensation, or others).
- Dyspnea of traumatic origin.
- Traumatic pneumothorax.
- Hemodynamic instability (PAM<65mmHg).
- Patients treated with Mobile Emergency and Resuscitation Service (SMUR) who have already received cardiac or pulmonary treatment.
- Patients with cognitive deterioration (Glasgow score less than 13, dementia or mental failure that would prevent good cooperation).
- Patients with lesion(s) of the oro-nasal sphere contraindicated for the implementation of High Flow Nasal Oxygen Therapy.
- Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator.
- Subject without health insurance.
- Pregnant woman.
- Subject being in the exclusion period of another study or included in the "national volunteer file".
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Interventions
Study participants are suffering from an acute hypoxemic respiratory distress. They have to be treated with oxygen-therapy that could be administered using a conventional oxygen device (study group "CO") or High Flow Nasal Oxygen (study group "HNFO"). During the first 60 minutes following patients admission, patients will be randomized to one of the two study groups. In both groups, the failure of the treatment will be evaluated by the need for a therapeutic escalation fours hours after the treatment initiation.
Locations(10)
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NCT04607967