COVID-19INVICTUSNCT04372680
WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound.
A study testing CTUS examination in people with COVID-19 and ARDS, Human, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
The most feared complication of COVID-19 infection is the occurrence of an acute respiratory distress syndrome (ARDS) that requires ICU admission and prolonged mechanical ventilation in more than 2% of the affected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS, Human, Mechanical Ventilation
- What is being tested?
- CTUS examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Apr 2020to 1 Apr 2022
- 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
- ICU admission for severe acute respiratory distress syndrome (ARDS, as previously defined5 by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 150) related to COVID-19.
- Non paralyzed because of neuromuscular blocking agents.
- Ventilated patient in pressure support mode for at least 6 hours and at most 24 hours.
- Surrogate decision maker's consent.
- Affiliated person or beneficiary of a social security scheme.
Who cannot join
- Reduction or cessation of active treatment.
- Paraplegia with medullar level more than T8.
- Tracheostomy before hospital admission.
- History of severe respiratory illness.
- Patient under juridical protection.
- Pregnancy or nursing woman.
- Enrolled in another trial evaluating mechanical ventilation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound: a Prospective, Multicenter, Randomized, Open-label, Parallel-group Clinical Trial
The most feared complication of COVID-19 infection is the occurrence of an acute respiratory distress syndrome (ARDS) that requires ICU admission and prolonged mechanical ventilation in more than 2% of the affected patients. Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Delayed extubation has several consequences such as patient's mortality, health-care-related complications, neuropsychological adverse events. The aim of the INVICTUS study is to evaluate whether a CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care.
Read the detailed description
Identifying patients at risk for postextubation distress using standard clinical criteria and the only available test the investigators have, that is, the spontaneous breathing trial (SBT) remains a challenging issue2. A cumulative body of evidence suggest that the decision to attempt extubation might be assisted by the use of thoracic ultrasound. This non-invasive, reproducible and fully bedside approach is able to provide accurate information about respiratory, cardiac and neuromuscular functions which are independent predictors of extubation outcome. Recently, the investigators have demonstrated that a combined thoracic ultrasound (CTUS) strategy based on lung ultrasound, echocardiography and diaphragm ultrasonographic assessment data performs better than routine clinical assessment to evaluate extubation readiness in medical and surgical ICU patients3. CTUS appears as a unique point of care precision medicine prognostic and diagnostic tool for the management of patients experiencing ARDS. Based on those premises, the investigators hypothesize that CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care. This research is a national, multicenter, randomized, controlled, open-label, in parallel group. Patients will be randomized on 1:1 CTUS strategy group or standard strategy group, daily daily followed until extubation+48hours, reassessed at day 28 and at 3 months. In CTUS strategy group, a combined CTUS examination will be performed until the day of patient extubation. CTUS examination will consist on a fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions. In standard strategy group, from the day of patient's inclusion and beyond every day, the clinical team in charge of patients will decide to perform or not an SBT following current recommendations2. These criteria are mainly based on clinical data and do not include any specific ultrasound assessment.
- Conditions
- COVID-19, ARDS, Human, Mechanical Ventilation
- Being tested
- CTUS examination
- Keywords
- COVID-19,, ARDS, Mechanical ventilation, Lung ultrasound, Echocardiography
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTUS examinationDiagnostic test
fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions
| Study group | Role | What they receive |
|---|---|---|
| CTUS strategy group | Experimental | CTUS examination will be performed until the day of patient extubation. CTUS examination will consist on a fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions Receives: Diagnostic Test: CTUS examination |
| standard strategy group | No intervention | from the day of patient's inclusion and beyond every day, the clinical team in charge of patients will decide to perform or not an SBT following current recommendations2. These criteria are mainly based on clinical data and do not include any specific ultrasound assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay from the start of Mechanical Ventilation weaning process to extubation
Delay from the start of MV weaning process (day of the switch from volume control mode to pressure support ventilation) to extubation (or spontaneously breathing through tracheostomy cannula) for at least 48 hours, as previously defined.
Measured: day 28
Secondary outcomes (3)
delay from intubation to extubation
delay from intubation to extubation
Measured: day 28
Successful of extubation
Successful of extubation if patient is not reintubated after 48 hours of extubation
Measured: day 28
mortality rate
mortality rate
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start22 Apr 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Controlled, open-label, in parallel group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice RIU-POULENC, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372680
- Sponsor's protocol ID
- RC31/20/0138
- Other IDs
- 2020-A00916-33
- Acronym
- INVICTUS
- Status last verified
- Oct 2023
- First submitted
- 30 Apr 2020
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound: a Prospective, Multicenter, Randomized, Open-label, Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT04372680
- Acronym / sponsor ID
- INVICTUS / RC31/20/0138
- Conditions
- COVID-19, ARDS, Human, Mechanical Ventilation
- Keywords
- COVID-19,, ARDS, Mechanical ventilation, Lung ultrasound, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 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.
The most feared complication of COVID-19 infection is the occurrence of an acute respiratory distress syndrome (ARDS) that requires ICU admission and prolonged mechanical ventilation in more than 2% of the affected patients. Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Delayed extubation has several consequences such as patient's mortality, health-care-related complications, neuropsychological adverse events. The aim of the INVICTUS study is to evaluate whether a CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care.
Detailed description
Identifying patients at risk for postextubation distress using standard clinical criteria and the only available test the investigators have, that is, the spontaneous breathing trial (SBT) remains a challenging issue2. A cumulative body of evidence suggest that the decision to attempt extubation might be assisted by the use of thoracic ultrasound. This non-invasive, reproducible and fully bedside approach is able to provide accurate information about respiratory, cardiac and neuromuscular functions which are independent predictors of extubation outcome. Recently, the investigators have demonstrated that a combined thoracic ultrasound (CTUS) strategy based on lung ultrasound, echocardiography and diaphragm ultrasonographic assessment data performs better than routine clinical assessment to evaluate extubation readiness in medical and surgical ICU patients3. CTUS appears as a unique point of care precision medicine prognostic and diagnostic tool for the management of patients experiencing ARDS. Based on those premises, the investigators hypothesize that CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care. This research is a national, multicenter, randomized, controlled, open-label, in parallel group. Patients will be randomized on 1:1 CTUS strategy group or standard strategy group, daily daily followed until extubation+48hours, reassessed at day 28 and at 3 months. In CTUS strategy group, a combined CTUS examination will be performed until the day of patient extubation. CTUS examination will consist on a fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions. In standard strategy group, from the day of patient's inclusion and beyond every day, the clinical team in charge of patients will decide to perform or not an SBT following current recommendations2. These criteria are mainly based on clinical data and do not include any specific ultrasound assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Controlled, open-label, in parallel group
| Arm | Type | Receives |
|---|---|---|
| CTUS strategy group | Experimental | Diagnostic Test: CTUS examinationCTUS examination will be performed until the day of patient extubation. CTUS examination will consist on a fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions |
| standard strategy group | No intervention | –from the day of patient's inclusion and beyond every day, the clinical team in charge of patients will decide to perform or not an SBT following current recommendations2. These criteria are mainly based on clinical data and do not include any specific ultrasound assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICU admission for severe acute respiratory distress syndrome (ARDS, as previously defined5 by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 150) related to COVID-19.
- Non paralyzed because of neuromuscular blocking agents.
- Ventilated patient in pressure support mode for at least 6 hours and at most 24 hours.
- Surrogate decision maker's consent.
- Affiliated person or beneficiary of a social security scheme.
Key exclusion criteria (7 listed)
- Reduction or cessation of active treatment.
- Paraplegia with medullar level more than T8.
- Tracheostomy before hospital admission.
- History of severe respiratory illness.
- Patient under juridical protection.
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 |
|---|---|---|
| CTUS examinationfully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions | Diagnostic test | CTUS strategy group |
Primary outcome
Delay from the start of Mechanical Ventilation weaning process to extubation
Time frame: day 28
Delay from the start of MV weaning process (day of the switch from volume control mode to pressure support ventilation) to extubation (or spontaneously breathing through tracheostomy cannula) for at least 48 hours, as previously defined.
3 secondary outcomes
delay from intubation to extubation
Time frame: day 28
Successful of extubation
Time frame: day 28
mortality rate
Time frame: day 28
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 17 Oct 2023.
- 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.
Béatrice RIU-POULENC principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTUS examination in people with COVID-19 and ARDS, Human, run by University Hospital, Toulouse at 2 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 5 inclusion and 7 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Delay from the start of Mechanical Ventilation weaning process to extubation (time frame: day 28). 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 17 Oct 2023.