NCT04607967

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

June 24, 2024

Status Verified

April 1, 2024

Enrollment Period

4.5 years

First QC Date

October 23, 2020

Last Update Submit

June 21, 2024

Conditions

Acute Hypoxemic Respiratory Distress

Outcome Measures

Primary Outcomes (1)

  • Therapeutic escalation

    The need for a therapeutic escalation will be searched 4 hours after treatment initiation (either Conventional Oxygen or High Flow Nasal Oxygen)

    4 hours after treatment initiation

Secondary Outcomes (3)

  • Identification of possible early prognostic factors for HFNO failure, defined as the need for a therapeutic escalation, within 60 minutes after its initiation.

    60 minutes after treatment initiation

  • Assessment of the effectiveness of HNFO on patient outcomes (Total time of HNFO use in the ED, ED length of stay, length and type of hospitalization, and patient's status at 30-day (deceased, still hospitalized or discharged from the hospital).)

    30 days after treatment initiation

  • Etiology of dyspnea

    30 days after treatment initiation

Study Arms (2)

Conventional oxygen-therapy (study group "CO")

NO INTERVENTION

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.

High Flow Nasal Oxygen (study group "HNFO")

EXPERIMENTAL

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.

Device: High Flow Nasal Oxygen

Interventions

High Flow Nasal OxygenDEVICE

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.

Also known as: HNFO (High Flow Nasal Oxygen)
High Flow Nasal Oxygen (study group "HNFO")

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital of Dijon

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

University Hospital of Besançon

Besançon, Franche Comté, 25000, France

RECRUITING

Hospital of Chartres

Chartres, France

RECRUITING

University Hospital of Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Montpellier University Hospital

Montpellier, France

RECRUITING

University Hospital of Lariboisière

Paris, 75000, France

RECRUITING

University Hospital of Poitiers

Poitiers, France

RECRUITING

University Hospital of Rennes

Rennes, France

RECRUITING

University Hospital of Toulouse

Toulouse, France

RECRUITING

Hospital of Vesoul

Vesoul, France

RECRUITING

Related Publications (1)

  • Pretalli JB, Parmentier AL, Mauny F, Desmettre T, Marjanovic N, Capellier G, Khoury A. Efficacy of high-flow nasal oxygen therapy started in the emergency room versus conventional oxygen therapy in patients with acute hypoxaemic respiratory distress: protocol for a French multicentric, prospective, open and randomised superiority study protocol (HIFLOWED). BMJ Open. 2024 Aug 19;14(8):e083262. doi: 10.1136/bmjopen-2023-083262.

    PMID: 39160110DERIVED

Central Study Contacts

Abdo Khoury, MD, MPH, MSc

CONTACT

33 3 81 66 88 36akhoury@chu-besancon.fr

Jean-Baptiste Pretalli, PhD

CONTACT

33 3 81 21 81 27jbpretalli@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 29, 2020

Study Start

November 23, 2020

Primary Completion

May 23, 2025

Study Completion

June 23, 2025

Last Updated

June 24, 2024

Record last verified: 2024-04

Locations

FR(10)