Respiratory Distress Syndrome, AdultNCT05210881
Weaning From Nasal High Flow Therapy
An observational study of Respiratory Distress Syndrome, Adult and Acute Hypoxemic Respiratory Failure, run by Hôpital Louis Mourier at 1 site in France.
Trial summary
Nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure. It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 31 Aug 2021
- 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: ICU patients treated with nasal high flow therapy
Who may be able to join
- ICU patient treated with nasal high flow
Who cannot join
- age < 18 years
- concomitant treatment with non-invasive ventilation
- acute hypercapnic respiratory failure
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: Weaning From Nasal High Flow Therapy: an Explorative Study Assessing the Usefulness of the ROX Index to Predict Outcome of the Weaning Process in Combination With a Withdrawal Trial
Nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure. It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients. The Respiratory Oxygenation (ROX) index has been established as a simple tool to help clinicians identify those patients who will succeed and those who will fail under nasal high flow and therefore predict the need for intubation. However, when nasal high flow therapy is successful, little is known as to how and when weaning of this device should be performed and what are the predictors of a safe withdrawal of the device. The objectives of this retrospective exploratory study are to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial; to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy.
Read the detailed description
Although nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure, and its benefits have been shown in multiple studies, little is known as to how and when weaning from the technique device should be performed and what are the predictors of a safe withdrawal. The Respiratory Oxygenation (ROX) index was established and tested to predict outcome of nasal high flow therapy in patients with acute hypoxemic respiratory failure. It combines three parameters available at the bedside that reflect patient's respiratory status: respiratory rate, the level of the inspired fraction of oxygen (FiO2) and pulse oximetry (SpO2). Importantly, the combination of these three parameters outweighed the performance of each parameter taken separately to predict nasal high flow therapy outcome. Since its initial publication, several studies coming from different countries have confirmed the potential for the ROX index to predict need for intubation in patients with acute hypoxemic respiratory failure, thus making a valuable tool accessible to everyone, including nurses, to monitor on a routine basis. Because it reflects the patient's respiratory status, the greater the score, the better the patient's condition. Hence, one may hypothesize that, at the other end of the spectrum of respiratory failure (i.e., at the stage of weaning and withdrawal of the high flow device when the patient has considerably improved), the ROX index may also help identify those patients who will be successfully separated from the nasal high flow support. To date, one study has suggested that among several parameters, the value of the ROX index could be associated with successful cessation of nasal high flow. Here, in a retrospective exploratory study, investigators aim to to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial (average duration of use of nasal high flow before weaning, number of weaning trials, number of failed and successful weaning trials.); to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy; A successful withdrawal is defined as the withdrawal of nasal high flow without necessity of placing the patient back on nasal high flow within the following 24h. A failed withdrawal is defined by the need to resume nasal high flow within the 24h hours following the withdrawal. The possible identification of a cut-off value may help clinicians initiate earlier weaning from nasal high flow.
- Conditions
- Respiratory Distress Syndrome, Adult, Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome, Weaning Failure
- Keywords
- nasal high flow oxygen, withdrawal from nasal high flow therapy, ROX index, acute hypoxemic respiratory failure, withdrawal trial
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded
Measured: through each nasal high flow therapy, that lasts an average of 24hours
Secondary outcomes (4)
use of nasal high flow before weaning
average duration of nasal high flow therapy before initiating a withdrawal trial (in hours)
Measured: through each nasal high flow therapy, that lasts an average of 24 hours
number of withdrawal trials
the number of trials each patient will have performed will be recorded
Measured: through each nasal high flow therapy, that lasts an average of 24 hours
number of patients who failed a withdrawal trial
withdrawal failure is defined by patients who required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
Measured: throughout study duration which is a one-year period
number of patients who succeeded a withdrawal trial
withdrawal success is defined by patients that have not required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
Measured: throughout study duration which is a one-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- NCT05210881
- Sponsor's protocol ID
- HLM_JDR11
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
PubMed 32901374Roca 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 30576221Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
PubMed 31511996
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Nasal High Flow Therapy: an Explorative Study Assessing the Usefulness of the ROX Index to Predict Outcome of the Weaning Process in Combination With a Withdrawal Trial
- ClinicalTrials.gov ID
- NCT05210881
- Acronym / sponsor ID
- HLM_JDR11
- Conditions
- Respiratory Distress Syndrome, Adult, Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome, Weaning Failure
- Keywords
- nasal high flow oxygen, withdrawal from nasal high flow therapy, ROX index, acute hypoxemic respiratory failure, withdrawal trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Jan 2022 (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 is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure. It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients. The Respiratory Oxygenation (ROX) index has been established as a simple tool to help clinicians identify those patients who will succeed and those who will fail under nasal high flow and therefore predict the need for intubation. However, when nasal high flow therapy is successful, little is known as to how and when weaning of this device should be performed and what are the predictors of a safe withdrawal of the device. The objectives of this retrospective exploratory study are to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial; to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy.
Detailed description
Although nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure, and its benefits have been shown in multiple studies, little is known as to how and when weaning from the technique device should be performed and what are the predictors of a safe withdrawal. The Respiratory Oxygenation (ROX) index was established and tested to predict outcome of nasal high flow therapy in patients with acute hypoxemic respiratory failure. It combines three parameters available at the bedside that reflect patient's respiratory status: respiratory rate, the level of the inspired fraction of oxygen (FiO2) and pulse oximetry (SpO2). Importantly, the combination of these three parameters outweighed the performance of each parameter taken separately to predict nasal high flow therapy outcome. Since its initial publication, several studies coming from different countries have confirmed the potential for the ROX index to predict need for intubation in patients with acute hypoxemic respiratory failure, thus making a valuable tool accessible to everyone, including nurses, to monitor on a routine basis. Because it reflects the patient's respiratory status, the greater the score, the better the patient's condition. Hence, one may hypothesize that, at the other end of the spectrum of respiratory failure (i.e., at the stage of weaning and withdrawal of the high flow device when the patient has considerably improved), the ROX index may also help identify those patients who will be successfully separated from the nasal high flow support. To date, one study has suggested that among several parameters, the value of the ROX index could be associated with successful cessation of nasal high flow. Here, in a retrospective exploratory study, investigators aim to to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial (average duration of use of nasal high flow before weaning, number of weaning trials, number of failed and successful weaning trials.); to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy; A successful withdrawal is defined as the withdrawal of nasal high flow without necessity of placing the patient back on nasal high flow within the following 24h. A failed withdrawal is defined by the need to resume nasal high flow within the 24h hours following the withdrawal. The possible identification of a cut-off value may help clinicians initiate earlier weaning from nasal high flow.
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
- ICU patients treated with nasal high flow therapy
Key inclusion criteria (1 listed)
- ICU patient treated with nasal high flow
Key exclusion criteria (3 listed)
- age < 18 years
- concomitant treatment with non-invasive ventilation
- acute hypercapnic respiratory failure
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
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
Time frame: through each nasal high flow therapy, that lasts an average of 24hours
the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded
4 secondary outcomes
use of nasal high flow before weaning
Time frame: through each nasal high flow therapy, that lasts an average of 24 hours
number of withdrawal trials
Time frame: through each nasal high flow therapy, that lasts an average of 24 hours
number of patients who failed a withdrawal trial
Time frame: throughout study duration which is a one-year period
number of patients who succeeded a withdrawal trial
Time frame: throughout study duration which is a one-year period
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 27 Jan 2022.
- Background: PubMed 32901374Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
- 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.
- Results publication: PubMed 31511996Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
- 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 Distress Syndrome, Adult and Acute Hypoxemic 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 1 inclusion and 3 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 27 Jan 2022. 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?
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal (time frame: through each nasal high flow therapy, that lasts an average of 24hours). 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 NCT05210881, which also lists 3 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 27 Jan 2022; AzTrials last refreshed its copy on 29 Oct 2026.