Efficacy of High Flow Nasal Oxygen Therapy Started in the Emergency Room Versus Conventional Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Distress

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
University Hospital of Besançon
RECRUITING
Besançon
Hospital of Chartres
RECRUITING
Chartres
University Hospital of Clermont Ferrand
RECRUITING
Clermont-ferrand
University Hospital of Dijon
RECRUITING
Dijon
Montpellier University Hospital
RECRUITING
Montpellier
University Hospital of Lariboisière
RECRUITING
Paris
University Hospital of Poitiers
RECRUITING
Poitiers
University Hospital of Rennes
RECRUITING
Rennes
University Hospital of Toulouse
RECRUITING
Toulouse
Hospital of Vesoul
RECRUITING
Vesoul
Contact Information
Primary
Abdo Khoury, MD, MPH, MSc
akhoury@chu-besancon.fr
33 3 81 66 88 36
Backup
Jean-Baptiste Pretalli, PhD
jbpretalli@chu-besancon.fr
33 3 81 21 81 27
Time Frame
Start Date: 2020-11-23
Estimated Completion Date: 2025-06-23
Participants
Target number of participants: 500
Treatments
No_intervention: Conventional oxygen-therapy (study group CO)
Patients randomized in the Conventional Oxygen group will be treated according to the national and international recommendations with a conventional oxygen-therapy device (nasal cannula or nasal-oral mask).~Treatment failure will be evaluated after 4 hours by the need for a therapeutic escalation.
Experimental: High Flow Nasal Oxygen (study group HNFO)
Patients randomized in the HNFO group will be treated according to the CE Marking with the high flow nasal oxygen device.~Treatment failure will be evaluated after 4 hours by the need for a therapeutic escalation.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon
Collaborators: University Hospital, Montpellier, Centre Hospitalier Universitaire de Saint Louis APHP, University Hospital, Toulouse, centre Hospitalier Intercommunal de Vesoul, Rennes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Clermont-Ferrand, Centre Hospitalier of Chartres, Poitiers University Hospital

This content was sourced from clinicaltrials.gov