Acute Respiratory Failure With HypoxiaDECIPHEROBSNCT03311087
Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure
An observational study of Acute Respiratory Failure With Hypoxia and Hypoxemia, run by Hôpital Louis Mourier at 10 sites in France.
Trial summary
Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia, Hypoxemia
- How many people
- 100 participants
- Where
- 10 sitesFrance
- Study dates
- 9 Jul 2018to Nov 2018
- Phase
- Observational
- 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
Study population: Adult patients admitted to an ICU or an intermediate care unit, who require nasal high flow oxygen therapy for acute hypoxemic respiratory failure
Who may be able to join
- Patients aged 18 or older
- admitted to the intensive care unit (ICU) or to the intermediate care for acute hypoxemic respiratory failure (whatever the cause)
- treated with nasal high flow oxygen therapy
- with a minimal FiO2 of FiO2≥50% and a gas flow ≥40 L/min
- anticipated duration of nasal high flow therapy greater or equal to 24 hours
- Non-inclusion Criteria:
- prophylactic, post-extubation nasal high flow therapy
- palliative nasal high flow therapy (do-not-resuscitate order)
Who cannot join
- nasal high flow therapy administered for less than 24 hours
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Service de Réanimation Médico-Chirurgicale
Colombes, 92700
Jean-Damien Ricard, MD, PhD, jean-damien.ricard@aphp.fr
Guillaume Berquier, MD, gberquier@yahoo.fr
- Recruiting
Service de Réanimation Médicale
Dijon
Jean-Pierre Quenot, MD, jean-pierre.quenot@chu-dijon.fr
- Recruiting
Service de Réanimation Médicale
Grenoble
Nicolas Terzi, MD, PhD, nterzi@chu-grenoble.fr
- Recruiting
Service de Réanimation
Longjumeau
Matthieu Le Meur, MD, m.lemeur@gh-nord-essonne.fr
- Recruiting
Service de Réanimation
Orléans
Isabelle Runge, MD, Isabelle.runge@chr-orleans.fr
- Recruiting
Service de Réanimation Médicale et Resiratoire
Paris
Elise Morawiec, MD, elisemorawiec@gmail.com
maxens Decavèle, MD, maxencesar@hotmail.fr
- Recruiting
Service de Réanimation Médicale
Paris
Ania nieszkowska, MD, ania.nieszkowska@aphp.fr
- Recruiting
Service de Réanimation
Poitiers
Jean-Pierre Frat, MD, Jean-Pierre.FRAT@chu-poitiers.fr
- Recruiting
Service de Réanimation Médicale
Rouen
Christophe Girault, MD, Christophe.Girault@chu-rouen.fr
- Recruiting
Service de Réanimation Médicale
Tours
stephan Hermann, MD, PhD, stephanehrmann@gmail.com
About this study
Official title: Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study
Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.
Read the detailed description
Nasal high flow oxygen therapy is increasingly used as a first-line treatment for hypoxemic acute respiratory failure, because of its remarkable tolerance (in comparison with NIV) and its physiological effects (nasopharyngeal dead space washout, positive end-expiratory pressure effect with possible alveolar recruitment, better matching with the patient's inspiratory flow, more reliable and adjustable FiO2); that together contribute to a reduction in respiratory workload and better oxygenation.
Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there are no data (and even less recommendations) on how to best conduct this technique, including its initiation and its weaning periods.
Because different approaches exist among clinicians, investigators believe that a multicenter observational study that would collect data regarding the different ways high flow is conducted in patients with acute respiratory failure is necessary before performing an interventional study that would test and compare different strategies in order to answer the question: what are the best strategies (in terms of flow and FiO2 settings) to initiate and to wean high-flow oxygen therapy in patients with acute respiratory failure?
Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.
- Conditions
- Acute Respiratory Failure With Hypoxia, Hypoxemia
- Keywords
- high flow nasal oxygen, acute hypoxemic respiratory failure, adults, intensive care unit
- Medical subject headings
- Hypoxia, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
values of gas flow over time (in liters per minute)
values of gas flow set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow
Measured: entire duration of high flow therapy (5 to 7 days)
values of fraction in inspired oxygen (FiO2) over time (between 0.21 and 1.0)
values of FiO2 set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow
Measured: entire duration of high flow therapy (5 to 7 days)
Secondary outcomes (3)
respiratory rate (breath per minute)
values of respiratory rate upon initiation of nasal high flow and at each change of nasal high flow parameters (gas flow or FiO2) will be monitored.
Measured: entire duration of high flow therapy (5 to 7 days)
pulse oximetry (SpO2) (percentage)
values of oxgen saturation upon initiation of nasal high flow and at each change of nasal high flow parameters (gas flow or FiO2) will be monitored.
Measured: entire duration of high flow therapy (5 to 7 days)
values of the Respiratory rate Oxygenation indeX ("ROX") index defined as the ratio of pulse oximetry over fraction of inspired oxygen to respiratory rate
values of the "ROX" index will be monitored at different time points (2, 6 and 12 hours after nasal high flow therapy initiation)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start9 Jul 2018
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Louis Mourier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Jean-Damien RICARD, Hôpital Louis Mourier
- Investigators
- Jean-Damien Ricard, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311087
- Sponsor's protocol ID
- HLM_JDR6
- Acronym
- DECIPHEROBS
- Status last verified
- Jul 2018
- First submitted
- 11 Oct 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PubMed 21946925Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
PubMed 21958974Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
PubMed 25371400Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.
PubMed 27481760
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT03311087
- Acronym / sponsor ID
- DECIPHEROBS / HLM_JDR6
- Conditions
- Acute Respiratory Failure With Hypoxia, Hypoxemia
- Keywords
- high flow nasal oxygen, acute hypoxemic respiratory failure, adults, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 16 Oct 2017 (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.
Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.
Detailed description
Nasal high flow oxygen therapy is increasingly used as a first-line treatment for hypoxemic acute respiratory failure, because of its remarkable tolerance (in comparison with NIV) and its physiological effects (nasopharyngeal dead space washout, positive end-expiratory pressure effect with possible alveolar recruitment, better matching with the patient's inspiratory flow, more reliable and adjustable FiO2); that together contribute to a reduction in respiratory workload and better oxygenation.
Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there are no data (and even less recommendations) on how to best conduct this technique, including its initiation and its weaning periods.
Because different approaches exist among clinicians, investigators believe that a multicenter observational study that would collect data regarding the different ways high flow is conducted in patients with acute respiratory failure is necessary before performing an interventional study that would test and compare different strategies in order to answer the question: what are the best strategies (in terms of flow and FiO2 settings) to initiate and to wean high-flow oxygen therapy in patients with acute respiratory failure?
Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to an ICU or an intermediate care unit, who require nasal high flow oxygen therapy for acute hypoxemic respiratory failure
Key inclusion criteria (8 listed)
- Patients aged 18 or older
- admitted to the intensive care unit (ICU) or to the intermediate care for acute hypoxemic respiratory failure (whatever the cause)
- treated with nasal high flow oxygen therapy
- with a minimal FiO2 of FiO2≥50% and a gas flow ≥40 L/min
- anticipated duration of nasal high flow therapy greater or equal to 24 hours
Key exclusion criteria (1 listed)
- nasal high flow therapy administered for less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
values of gas flow over time (in liters per minute)
Time frame: entire duration of high flow therapy (5 to 7 days)
values of gas flow set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow
values of fraction in inspired oxygen (FiO2) over time (between 0.21 and 1.0)
Time frame: entire duration of high flow therapy (5 to 7 days)
values of FiO2 set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow
3 secondary outcomes
respiratory rate (breath per minute)
Time frame: entire duration of high flow therapy (5 to 7 days)
pulse oximetry (SpO2) (percentage)
Time frame: entire duration of high flow therapy (5 to 7 days)
values of the Respiratory rate Oxygenation indeX ("ROX") index defined as the ratio of pulse oximetry over fraction of inspired oxygen to respiratory rate
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- Background: PubMed 21946925Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
- Background: PubMed 21958974Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
- Background: PubMed 25371400Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
- Background: PubMed 27481760Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Damien Ricard, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure With Hypoxia and Hypoxemia, run by Hôpital Louis Mourier 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 8 inclusion and 1 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 20 Jul 2018. 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 Jean-Damien Ricard, MD, PhD (+33147606195, jean-damien.ricard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
values of gas flow over time (in liters per minute) (time frame: entire duration of high flow therapy (5 to 7 days)). The study lists 2 primary outcomes in all. 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 NCT03311087, which also lists 5 linked publications.
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 20 Jul 2018.