Respiratory FailureDE-RISK WFNCT04696406
Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
An observational study of Respiratory Failure, run by Respinor AS at 9 sites in 3 countries.
Trial summary
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- RESPINOR DXT
- Type of treatment
- Medical device
- How many people
- 193 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 11 May 2021to 30 Apr 2022
- How long will I take part?
- 21 Days
- 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: Patients under invasive mechanical ventilation in the intensive care unit
Who may be able to join
- Patients willing and able to give informed consent (either themselves or next of kin)
- Have undergone invasive mechanical ventilation > 24 hours
- Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):
- Adequate cough
- Absence of excessive tracheobronchial secretion
- Resolution of disease acute phase for which the patient was intubated
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- Clinical stability, defined as stable cardiovascular status (i.e. fC < 140 beats·min-1, systolic BP 90-160 mmHg, no or minimal vasopressors) and stable metabolic status
- Adequate oxygenation, defined as SaO2 > 90% on < FIO2 0.4 (or PaO2/FIO2 > 150 mmHg) and PEEP < 8 cmH2O
- Adequate pulmonary function, i.e. fR < 35 breaths·min-1
- Adequate mentation, defined as no sedation or adequate mentation on sedation (or stable neurologic patient), i.e., patient awake, calm and responsive to simple orders (squeeze hand, knock the head, close the eyes), no agitation.
Who cannot join
- Not registered with a social security system nor entitled to be
- Central or spinal neurological injury involving central ventilatory control
- Presence of a neuromuscular disease involving respiratory muscles
- Use of muscle-paralyzing agents within 24h before the study, except if given for intubation
- Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome > 2.5 cm compared to the contralateral dome
- Tracheostomy
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- Body mass index >35 kg/m2
- Patient with therapeutic limitation, i.e. reduced expectancy to survive
- Pregnant woman or protected adult
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France6 sites
Centre Hospitalier Universitaire d'Angers
Angers
Centre Hospitalier Saint Joseph Saint Luc
Lyon
Hôpitaux Universitaires de Marseille - AP-HM
Marseille, Chem. Des Bourrely, 13015
Centre Hospitalier Universitaire de Montpellier
Montpellier, Select One..., 34090
Hopital Saint-Antoine
Paris, Cedex 12, 75571
Hôpital Universitaire Pitié Salpêtrière
Paris
Norway2 sites
Oslo University Hospital
Oslo
St. Olavs University Hospital
Trondheim
About this study
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT). Continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.
All patients on mechanical ventilation in the ICU meeting the eligibility criteria shall undergo a daily screen for weaning readiness. If any of the components of the daily screen is not met, the patient will not undergo a SBT that day and continued to be screened daily. Patients passing daily screening criteria shall automatically receive an SBT.
Read more
The SBT shall last for 30-120 minutes and be performed on continuous positive airway pressure up to 5 cm H2O and pressure support up to 7 cm H2O. The SBT shall be terminated and mechanical ventilation reinstituted at the original settings if the patient meets any of the SBT failure criteria.
A trial is considered successful and physicians will be asked to approve extubation when the patient can breathe spontaneously for the whole trial.
Patients shall be continued to be screened daily until extubation, 21 days after enrolment, performance of tracheostomy, death, or withdrawal of care. All patients shall be followed until hospital discharge or death.
- Conditions
- Respiratory Failure
- Being tested
- RESPINOR DXT
- Keywords
- Diaphragm ultrasound, Diaphragm function, Mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPINOR DXTDevice
Blinded, continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.
| Study group | Role | What they receive |
|---|---|---|
| Weaning failure | Defined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours Receives: Device: RESPINOR DXT | |
| Weaning success | Defined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation. Receives: Device: RESPINOR DXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm.
Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE < 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE > 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
Measured: Second minute of the first SBT
Secondary outcomes (5)
Difference in the rate of weaning failure with reintubation failure 72 hours and 7 days after extubation between patients with a DE <1.1 cm compared to those with a DE >1.1 cm.
Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE < 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE > 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
Measured: Second minute of the first SBT
Subgroup analysis on the difference in the rate of weaning failure between patients with a DE <1.1 cm compared to those with a DE >1.1 cm excluding COVID-19 patients. Similar subgroup analysis for COVID-19 patients.
Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE < 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE > 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
Measured: Second minute of the first SBT
Correlation between median DE measurements taken during the second minute of the SBT and duration of mechanical ventilation prior to the first SBT, after the SBT and total mechanical ventilation time.
Plots of DE values versus MV duration will be presented, together with the estimated correlation coefficient.
Measured: Second minute of the first SBT
Correlation between median DE measurements taken during the second minute of the SBT and duration of ICU stay prior to the first SBT, after the SBT and total ICU time.
Plots of DE values versus ICU duration will be presented, together with the estimated correlation coefficient.
Measured: Second minute of the first SBT
Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.
Thresholds for continuous DE will be defined by ROC curve analysis.
Measured: Second minute of the first SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start11 May 2021
- Primary completion30 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Prospective
- Enrolment
- 193 participants (actual)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Respinor AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Alexandre Demoule, MD, Principal investigator, Hôpital Universitaire Pitié SalpêtrièreMichele Umbrello, MD, Principal investigator, Ospedale San Carlo BorromeoØyvind Skraastad, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696406
- Sponsor's protocol ID
- DXT-CS-005
- Acronym
- DE-RISK WF
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
- ClinicalTrials.gov ID
- NCT04696406
- Acronym / sponsor ID
- DE-RISK WF / DXT-CS-005
- Conditions
- Respiratory Failure
- Keywords
- Diaphragm ultrasound, Diaphragm function, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Respinor ASIndustry (pharma, biotech, devices)
- Collaborators
- The Research Council of Norway
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Jan 2021 (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.
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT). Continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.
All patients on mechanical ventilation in the ICU meeting the eligibility criteria shall undergo a daily screen for weaning readiness. If any of the components of the daily screen is not met, the patient will not undergo a SBT that day and continued to be screened daily. Patients passing daily screening criteria shall automatically receive an SBT.
The SBT shall last for 30-120 minutes and be performed on continuous positive airway pressure up to 5 cm H2O and pressure support up to 7 cm H2O. The SBT shall be terminated and mechanical ventilation reinstituted at the original settings if the patient meets any of the SBT failure criteria.
A trial is considered successful and physicians will be asked to approve extubation when the patient can breathe spontaneously for the whole trial.
Patients shall be continued to be screened daily until extubation, 21 days after enrolment, performance of tracheostomy, death, or withdrawal of care. All patients shall be followed until hospital discharge or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning failure | – | Device: RESPINOR DXTDefined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours |
| Weaning success | – | Device: RESPINOR DXTDefined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under invasive mechanical ventilation in the intensive care unit
Key inclusion criteria (10 listed)
- Patients willing and able to give informed consent (either themselves or next of kin)
- Have undergone invasive mechanical ventilation > 24 hours
- Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):
Key exclusion criteria (9 listed)
- Not registered with a social security system nor entitled to be
- Central or spinal neurological injury involving central ventilatory control
- Presence of a neuromuscular disease involving respiratory muscles
- Use of muscle-paralyzing agents within 24h before the study, except if given for intubation
- Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome > 2.5 cm compared to the contralateral dome
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 |
|---|---|---|
| RESPINOR DXTBlinded, continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT. | Device | Weaning failure, Weaning success |
Primary outcome
Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm.
Time frame: Second minute of the first SBT
Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE < 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE > 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
5 secondary outcomes
Difference in the rate of weaning failure with reintubation failure 72 hours and 7 days after extubation between patients with a DE <1.1 cm compared to those with a DE >1.1 cm.
Time frame: Second minute of the first SBT
Subgroup analysis on the difference in the rate of weaning failure between patients with a DE <1.1 cm compared to those with a DE >1.1 cm excluding COVID-19 patients. Similar subgroup analysis for COVID-19 patients.
Time frame: Second minute of the first SBT
Correlation between median DE measurements taken during the second minute of the SBT and duration of mechanical ventilation prior to the first SBT, after the SBT and total mechanical ventilation time.
Time frame: Second minute of the first SBT
Correlation between median DE measurements taken during the second minute of the SBT and duration of ICU stay prior to the first SBT, after the SBT and total ICU time.
Time frame: Second minute of the first SBT
Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.
Time frame: Second minute of the first SBT
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 19 Dec 2023.
- 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.
Alexandre Demoule, MD principal investigator
Hôpital Universitaire Pitié Salpêtrière
Michele Umbrello, MD principal investigator
Ospedale San Carlo Borromeo
Øyvind Skraastad, MD principal investigator
Oslo University Hospital
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Respinor AS at 9 sites in 3 countries.
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 10 inclusion and 9 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Norway, Italy. 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?
Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm. (time frame: Second minute of the first SBT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.