Respiratory Syndrome, Acute, SevereNCT04385823
Use of High Flow Nasal Cannula Oxygen and Covid-19 Acute Hypoxemic Respiratory Failure
An observational study of Respiratory Syndrome, Acute, Severe and Hypoxic Respiratory Failure, run by Hôpital Louis Mourier at 1 site in France.
Trial summary
Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syndrome, Acute, Severe, Hypoxic Respiratory Failure, Viral Pneumonia
- What is being tested?
- patients receiving nasal high flow
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 4 May 2020
- 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: all adult patients admitted to the ICU with proven Covid-19 pneumonia and acute hypoxemic respiratory failure requiring supplemental oxygen administered via NHF
Who may be able to join
- Covid-19 pneumonia
- acute hypoxemic respiratory failure
- need for nasal high flow therapy as first line therapy
- admission to intensive care
Who cannot join
- intubation prior to NHF therapy
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
Colombes, 92700
About this study
Official title: Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study
Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.
Read the detailed description
Nasal High Flow oxygen therapy (NHF) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (AHRF). For various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), NHF seems to have been seldomly used during the current Covid-19 epidemic in France. However, the World Health Organization, and other scientific societies list NHF among the possible options for ventilatory support.
One of the risks however, identified with NHF is to delay an intubation that would have become necessary. This delay seems to be associated with a poorer prognosis for patients.
The respiratory-oxygenation index (termed ROX index) (defined as the ratio of pulse oximetry (SpO2) over inspired fraction in oxygen (FiO2) over respiratory rate (RR); SpO2/FiO2/RR) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on NHF for AHRF. In investigators'ICU, NHF is used in patients admitted for AHRFrelated to Covid-19 and the ROX index is measured and monitoring in investigators' patients. Investigators' initial experience - consistent with feedback from other ICUs - suggests that the respiratory rate of patients with Covid-19-related AHRF is sometimes lower than would be expected given the depth of the hypoxemia. In this case, the ROX index thresholds previously identified for predicting the success or failure of NHF could be different in the case of Covid-19-associated AHRF. The purpose of this work is to describe the use of NHF in Covid-19 patients with AHRF and the evolution of the ROX score over time in patients initially treated with NHF.
- Being tested
- patients receiving nasal high flow
- Medical subject headings
- Severe Acute Respiratory Syndrome, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients receiving nasal high flowDevice
patients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ROX index
values of ROX index during ICU stay
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary outcomes (7)
NHF failure
percentage of patients requiring intubation
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
NHF flow
level of flow used with NHF
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
NHF inspired fraction in oxygen
level of inspired fraction in oxygen used with NHF
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
oxygenation
level of pulse oxymetry during NHF therapy
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
respiratory status
respiratory rate during NHF therapy
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
prediction of intubation
defining the values of ROX index associated with intubation
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
prediction of NHF success
defining the values of ROX index associated with NHF success (no intubation required)
Measured: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Mar 2020
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syndrome, Acute, SevereStudies 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
- Retrospective
- Enrolment
- 62 participants (actual)
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
- NCT04385823
- Sponsor's protocol ID
- HLM_JDR9
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
PubMed 30576221Roca 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study
- ClinicalTrials.gov ID
- NCT04385823
- Acronym / sponsor ID
- HLM_JDR9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 13 May 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.
Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.
Detailed description
Nasal High Flow oxygen therapy (NHF) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (AHRF). For various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), NHF seems to have been seldomly used during the current Covid-19 epidemic in France. However, the World Health Organization, and other scientific societies list NHF among the possible options for ventilatory support.
One of the risks however, identified with NHF is to delay an intubation that would have become necessary. This delay seems to be associated with a poorer prognosis for patients.
The respiratory-oxygenation index (termed ROX index) (defined as the ratio of pulse oximetry (SpO2) over inspired fraction in oxygen (FiO2) over respiratory rate (RR); SpO2/FiO2/RR) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on NHF for AHRF. In investigators'ICU, NHF is used in patients admitted for AHRFrelated to Covid-19 and the ROX index is measured and monitoring in investigators' patients. Investigators' initial experience - consistent with feedback from other ICUs - suggests that the respiratory rate of patients with Covid-19-related AHRF is sometimes lower than would be expected given the depth of the hypoxemia. In this case, the ROX index thresholds previously identified for predicting the success or failure of NHF could be different in the case of Covid-19-associated AHRF. The purpose of this work is to describe the use of NHF in Covid-19 patients with AHRF and the evolution of the ROX score over time in patients initially treated with NHF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adult patients admitted to the ICU with proven Covid-19 pneumonia and acute hypoxemic respiratory failure requiring supplemental oxygen administered via NHF
Key inclusion criteria (4 listed)
- Covid-19 pneumonia
- acute hypoxemic respiratory failure
- need for nasal high flow therapy as first line therapy
- admission to intensive care
Key exclusion criteria (1 listed)
- intubation prior to NHF therapy
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 |
|---|---|---|
| patients receiving nasal high flowpatients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow | Device | – |
Primary outcome
Changes in ROX index
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
values of ROX index during ICU stay
7 secondary outcomes
NHF failure
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
NHF flow
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
NHF inspired fraction in oxygen
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
oxygenation
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
respiratory status
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
prediction of intubation
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
prediction of NHF success
Time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Background: PubMed 30576221Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
- 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: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syndrome, Acute, Severe and Hypoxic Respiratory Failure, run by Hôpital Louis Mourier at 1 site 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 4 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: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ROX index (time frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months). 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 NCT04385823, which also lists 2 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 13 May 2020.