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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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.
10 sites in 1 country
France10 sites, 10 recruiting
- 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
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.
- Conditions
- Acute Hypoxemic Respiratory Distress
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High Flow Nasal Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted29 Oct 2020
- Study start23 Nov 2020
- Primary completion23 May 2025 (estimated)
- Study completion23 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, centre Hospitalier Intercommunal de Vesoul, Centre Hospitalier Universitaire de Saint Louis APHP, Poitiers University Hospital, University Hospital, Clermont-Ferrand, Rennes University Hospital, Centre Hospitalier of Chartres, University Hospital, Toulouse, University Hospital, Montpellier
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04607967
- Acronym / sponsor ID
- HIFLOWED / 2020/472
- Conditions
- Acute Hypoxemic Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, centre Hospitalier Intercommunal de Vesoul, Centre Hospitalier Universitaire de Saint Louis APHP, Poitiers University Hospital, University Hospital, Clermont-Ferrand, Rennes University Hospital, Centre Hospitalier of Chartres, University Hospital, Toulouse, University Hospital, Montpellier
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 23 Jun 2025 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: High Flow Nasal OxygenPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal OxygenAlso: 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. | Device | High Flow Nasal Oxygen (study group "HNFO") |
Primary outcome
Therapeutic escalation
Time frame: 4 hours after treatment initiation
The need for a therapeutic escalation will be searched 4 hours after treatment initiation (either Conventional Oxygen or High Flow Nasal Oxygen)
3 secondary outcomes
Identification of possible early prognostic factors for HFNO failure, defined as the need for a therapeutic escalation, within 60 minutes after its initiation.
Time frame: 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).)
Time frame: 30 days after treatment initiation
Etiology of dyspnea
Time frame: 30 days after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 39160110Pretalli 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.
- Individual participant dataSharing planned: Undecided. The data in this study are not publicly available, but reasonable requests can be made to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
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.