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Acute Hypoxemic Respiratory DistressHIFLOWEDNCT04607967

HFNO or Conventional Oxygen Therapy for Patients With Acute Hypoxemic Respiratory Distress

A study testing High Flow Nasal Oxygen in people with Acute Hypoxemic Respiratory Distress, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Hypoxemic Respiratory Distress
What is being tested?
High Flow Nasal Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
10 sitesFrance
Study dates
23 Nov 2020to 23 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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".

Trial locations and contacts

10 sites in 1 country.

Abdo Khoury, MD, MPH, MSc contact

33 3 81 66 88 36

akhoury@chu-besancon.fr

Jean-Baptiste Pretalli, PhD contact

33 3 81 21 81 27

jbpretalli@chu-besancon.fr

10 sites in 1 country

France10 sites, 10 recruiting
  • University Hospital of Besançon

    Besançon, Franche Comté, 25000

    Abdo Khoury, MD,MPH, MSc, 33 3 81 66 88 36, akhoury@chu-besancon.fr

    Jean-Baptiste Pretalli, PhD, 33 3 81 21 81 27, jbpretalli@chu-besancon.fr

    Recruiting
  • Hospital of Chartres

    Chartres

    Paul Bachelier, MD

    Recruiting
  • University Hospital of Clermont Ferrand

    Clermont-Ferrand

    Jean-Baptiste Bouillon, MD

    Recruiting
  • University Hospital of Dijon

    Dijon, Bourgogne-Franche-Comté, 21000

    Didier Honnart, MD, PhD, Didier.honnart@chu-dijon.fr

    Eleonore TIMSIT, MD, PhD, eleonore.timsit@chu-dijon.fr

    Recruiting
  • Montpellier University Hospital

    Montpellier

    Mustapha Sebbane, MD, PhD

    Recruiting
  • University Hospital of Lariboisière

    Paris, 75000

    Anthony Chavin, MD, PhD, anthony.chauvin@aphp.fr

    Patrick Plaisance, MD, PhD, patrick.plaisance@aphp.fr

    Recruiting
  • University Hospital of Poitiers

    Poitiers

    Nicolas Marjanovic, MD, PhD, nicolas.marjanovic@chu-poitiers.fr

    Recruiting
  • University Hospital of Rennes

    Rennes

    Nicolas Peschanski, MD, PhD

    Recruiting
  • University Hospital of Toulouse

    Toulouse

    Frédéric Balen, MD

    Recruiting
  • Hospital of Vesoul

    Vesoul

    Toufiq El Cadi, MD, PhD, toufiq.elcadi@orange.fr

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Read the detailed description

Acute Respiratory Distress (ARD) is defined as the inability of a patient to maintain normal hematosis. A hematosis disorder is defined as an alteration of the blood gases with hypoxemia (partial pressure of oxygen (PaO2) less than 80 mm of mercury (mmHg) and transcutaneous O2 saturation (SpO2) less than 95%), associated or not with hypercapnia (partial pressure of carbon dioxide (PaCO2) > 45 mmHg) or hypocapnia depending on the cause of the acute respiratory failure. Compensation mechanisms include increased minute ventilation, increased ventilatory work and increased cardiac output. When these compensatory mechanisms are insufficient, acute respiratory distress occurs, along with signs of heart failure (acute cor pulmonale) and neuropsychic disorders.

Without care, a potentially fatal respiratory decompensation may occur. ARD can be hypercapnic. It's defined as a PaCO2 greater than 45 mm Hg associated with a drop in blood pH reflecting respiratory acidosis. Hypoxemic ARD is defined as a PaO2 of less than 60 mm Hg.

A quarter of the patients admitted to the Vital Emergency Room 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. Most experts stress the importance of having an SpO2 target of more than 90% in the majority of patients. While non-invasive ventilation (NIV) is the standard of care in the initial management of patients with hypercapnic acidosis, there are currently no recommendations for oxygen therapy in patients with acute hypoxic respiratory distress in the emergency department.

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. They offer several Oxygen Inspired Fraction (fraction of O2 in the gas mixture breathed, FiO2) depending on the oxygen flow rate instituted.

High Flow Nasal Oxygen (HFNO) is used as a complement to conventional oxygen therapy in emergency departments in general and in particular in the different emergency departments participating in our study. HFNO is used in hypoxemic respiratory insufficiency according to the national and international recommendations.

HFNO makes it possible to administer a much higher flow of oxygen than with the usual hospital and prehospital flow meters. This flow rate can go up to 60-70 L/min with an FIO2 of 100%. This high flow rate allows to generate low levels of positive pressure in the upper airways and to adapt the FIO2 delivered up to 100% notably thanks to dedicated nasal cannulas. HFNO ensures good clinical tolerance and better patient comfort (humidification and heating of inhaled gases ...) than the other oxygen devices. Its use was initially developed in paediatric and neonatal intensive care units. It was then gradually extended to "adult" intensive care units and intensive care units in the treatment of hypoxemic, non-hypercapnic acute respiratory failure (ARF) with no indication for orotracheal intubation. The FLORALI study confirms its use as an alternative to conventional oxygen therapy in intensive care units. Its implementation, its efficacy (improvement of dyspnea, clinical respiratory signs and oxygenation parameters), its good tolerance and acceptability by the nursing staff, were recently demonstrated in an emergency department in 17 patients with hypoxic respiratory insufficiency. However, despite the increasing number of studies, methodologically heterogeneous and of insufficient statistical power, carried out on HFNO, these studies remain non-contributory with regard to the superiority of high nasal flow compared to conventional oxygen therapy. The gain of the HFNO strategy seems to be established for clinical ventilatory parameters and dyspnea level. However, the need for therapeutic escalation and mortality have not been precisely evaluated. On the other hand, there is very little information on the time required for the implementation of HFNO in the various studies carried out in patients. The available data indicate that the average time would usually be more than 90 minutes.

Given the lack of data and clinical trials concerning the systematic use of HFNO in emergency departments 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 emergency department, 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.

Being tested
High Flow Nasal Oxygen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Flow Nasal OxygenDevice

    Also called HNFO (High Flow Nasal Oxygen)

    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.

Study groups in NCT04607967
Study groupRoleWhat they receive
Conventional oxygen-therapy (study group "CO")No interventionPatients 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")ExperimentalPatients 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.
Receives: Device: High Flow Nasal Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 4 hours after treatment initiation

Secondary outcomes (3)
  1. Identification of possible early prognostic factors for HFNO failure, defined as the need for a therapeutic escalation, within 60 minutes after its initiation.

    Clinical criteria (respiratory rate, SpO2, signs of respiratory failure (pulling, laboured breathing), dyspnoea score measured by the modified Borg scale).

    Paraclinical criteria: PaO2/FIO2 ratio<300mmHg.

    Measured: 60 minutes after treatment initiation

  2. 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).)

    Measured: 30 days after treatment initiation

  3. Etiology of dyspnea

    To describe the aetiology of dyspnoea (impairment of pulmonary neuromuscular function, secondary to chronic or acute obstructive pulmonary diseases, alveolar processes, vascular diseases, COVID, other).

    Measured: 30 days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start23 Nov 2020
  3. Primary completion23 May 2025 (estimated)
  4. Study completion23 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607967
Sponsor's protocol ID
2020/472
Acronym
HIFLOWED
Status last verified
Apr 2024
First submitted
23 Oct 2020
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data in this study are not publicly available, but reasonable requests can be made to the corresponding author.

Publications

  • 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.

    PubMed 39160110

Questions about this trial

What is this clinical trial studying?

A study testing High Flow Nasal Oxygen in people with Acute Hypoxemic Respiratory Distress, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abdo Khoury, MD, MPH, MSc (33 3 81 66 88 36, akhoury@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic escalation (time frame: 4 hours after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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