Pulmonary UltrasoundECHOEXTUBNCT05944588
Predictive Value of Chest Ultrasound Observation on Extubation Failure
An observational study of Pulmonary Ultrasound and Weaning Failure, run by University Hospital, Caen at 1 site in France.
Trial summary
The use of mechanical ventilation in intensive care concerns the majority of patients, most often to compensate for respiratory failure, but for other organic failures requiring therapeutic artificial coma. During the sedation phase, many elements of management can modify the patient's clinical parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Ultrasound, Weaning Failure, Ultrasound
- What is being tested?
- Pulmonary Ultrasound
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 22 May 2024
- How long will I take part?
- 7 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: All patients in the intensive care unit of the University hospital of Caen, presenting the Eligibility criteria without any exclusion criteria, intubated since more than 48h, presenting the common criteria of the unit to start a ventilatory weaning test
Who may be able to join
- Adult patient with organ failure requiring intubation for more than 48 hours
- In spontaneous ventilation with pressure support
- Presenting the common criteria of the unit to start a ventilatory weaning test
- Richmond Agitation Sedation Scale 0
Who cannot join
- Sedated patient with a score of 0 at the Richmond Agitation Sedation Scale
- Pregnant woman
- Patient under guardianship or curators or deprived of public rights
- Patient with a contraindication to performing an external ultrasound
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Center
Caen, Calvados, 14000
Damien Du Cheyron, PHD, 0231064716 ext. 4716, ducheyron-d@chu-caen.fr
Arthur PLE, Intern
About this study
The use of mechanical ventilation in intensive care concerns the majority of patients, most often to compensate for respiratory failure, but for other organic failures requiring therapeutic artificial coma. During the sedation phase, many elements of management can modify the patient's clinical parameters.
Indeed, mechanical ventilation with a positive expiratory pressure mainly modifies the venous return by decreasing it, and therefore many modifications of the hemodynamic parameters result from it. In addition, other elements of management, such as iterative fillings, vasopressor and inotropic amines, as well as sedative drugs not only modify the hemodynamics, but also the ventilatory mechanics.
Read more
Extubate a patient in intensive care is always complex, because the assessment must be multifactorial and this is not without risk for the patient. Many complications can arise if it ends in failure. They can be linked to mechanical causes (laryngeal oedema, tracheal stenosis, pneumothorax...) but also to non-mechanical causes, such as inappropriate sedation, overload, neuromuscular deficit. Extubation is primarily based on the patient's level of consciousness, as well as the successful progress of the patient during a ventilatory weaning trial, carried out after a return to spontaneous ventilation with inspiratory support. This ventilatory weaning test precedes extubation and is performed for any patient intubated for more than 48 hours.
Since the 1950s, ultrasounds have become more and more important in the field of medical diagnosis and therapeutic decision support, even more recently in the world of intensive care. The contribution of echocardiography in a patient in the process of extubation has already been evaluated and has proven to be a valuable aid. For nearly 20 years, the use of pulmonary ultrasound has emerged and allows rapid diagnosis at the patient's bedside of mechanical anomalies such as gaseous or liquid effusion, an anomaly in the compliance of the pulmonary parenchyma, possibly in link with diaphragmatic dysfunction or even signs in favor of a picture of pulmonary overload, thanks to ultrasound artefacts such as B lines or even alveolar derecruitment by atelectasis.
The role of pulmonary ultrasound in helping to decide on extubation remains poorly established, we propose an observational study evaluating the predictive value of chest ultrasound in pre-extubation with the aim of determining if ultrasound signs are able to predict a potential failure of this extubation. Indeed, the risks of extubation failure being much higher than those of ventilatory weaning failure, it seems necessary to focus our research on this component.
This study must include patients in spontaneous mechanical invasive ventilation with pressure support, presenting the criteria for a ventilatory weaning test in view of a potential extubation.
- Being tested
- Pulmonary Ultrasound
- Keywords
- Extubation, Weaning Failure, Lung Ultrasound, Chest Ultrasound, B Lines
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary UltrasoundOther
2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation
| Study group | Role | What they receive |
|---|---|---|
| Extubation Success | Patients who don't need a new intubation in the 7 days following the extubation Receives: Other: Pulmonary Ultrasound | |
| Extubation Failure | Patients who need a new intubation in the 7 days following the extubation Receives: Other: Pulmonary Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if pulmonary ultrasound observations are predictive factors linked with extubation failure
See if there's more pathological ultrasound signs in the extubation failure group
Measured: 7 days
Secondary outcomes (1)
Determine at wich range of pathological ultrasound observations there's a positive correlation with extubation failure
See if there 's a specific range number of pathological observations, where we can start to see a link with the extubation failure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start24 May 2023
- Primary completion22 May 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary UltrasoundStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien DD DUCHEYRON, PHD, Principal investigator, University Hospital Center of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944588
- Sponsor's protocol ID
- 23-0031
- Acronym
- ECHOEXTUB
- Status last verified
- May 2023
- First submitted
- 6 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Chest Ultrasound Observation on Extubation Failure
- ClinicalTrials.gov ID
- NCT05944588
- Acronym / sponsor ID
- ECHOEXTUB / 23-0031
- Keywords
- Extubation, Weaning Failure, Lung Ultrasound, Chest Ultrasound, B Lines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 13 Jul 2023 (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 use of mechanical ventilation in intensive care concerns the majority of patients, most often to compensate for respiratory failure, but for other organic failures requiring therapeutic artificial coma. During the sedation phase, many elements of management can modify the patient's clinical parameters.
Indeed, mechanical ventilation with a positive expiratory pressure mainly modifies the venous return by decreasing it, and therefore many modifications of the hemodynamic parameters result from it. In addition, other elements of management, such as iterative fillings, vasopressor and inotropic amines, as well as sedative drugs not only modify the hemodynamics, but also the ventilatory mechanics.
Extubate a patient in intensive care is always complex, because the assessment must be multifactorial and this is not without risk for the patient. Many complications can arise if it ends in failure. They can be linked to mechanical causes (laryngeal oedema, tracheal stenosis, pneumothorax...) but also to non-mechanical causes, such as inappropriate sedation, overload, neuromuscular deficit. Extubation is primarily based on the patient's level of consciousness, as well as the successful progress of the patient during a ventilatory weaning trial, carried out after a return to spontaneous ventilation with inspiratory support. This ventilatory weaning test precedes extubation and is performed for any patient intubated for more than 48 hours.
Since the 1950s, ultrasounds have become more and more important in the field of medical diagnosis and therapeutic decision support, even more recently in the world of intensive care. The contribution of echocardiography in a patient in the process of extubation has already been evaluated and has proven to be a valuable aid. For nearly 20 years, the use of pulmonary ultrasound has emerged and allows rapid diagnosis at the patient's bedside of mechanical anomalies such as gaseous or liquid effusion, an anomaly in the compliance of the pulmonary parenchyma, possibly in link with diaphragmatic dysfunction or even signs in favor of a picture of pulmonary overload, thanks to ultrasound artefacts such as B lines or even alveolar derecruitment by atelectasis.
The role of pulmonary ultrasound in helping to decide on extubation remains poorly established, we propose an observational study evaluating the predictive value of chest ultrasound in pre-extubation with the aim of determining if ultrasound signs are able to predict a potential failure of this extubation. Indeed, the risks of extubation failure being much higher than those of ventilatory weaning failure, it seems necessary to focus our research on this component.
This study must include patients in spontaneous mechanical invasive ventilation with pressure support, presenting the criteria for a ventilatory weaning test in view of a potential extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation Success | – | Other: Pulmonary UltrasoundPatients who don't need a new intubation in the 7 days following the extubation |
| Extubation Failure | – | Other: Pulmonary UltrasoundPatients who need a new intubation in the 7 days following the extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the intensive care unit of the University hospital of Caen, presenting the Eligibility criteria without any exclusion criteria, intubated since more than 48h, presenting the common criteria of the unit to start a ventilatory weaning test
Key inclusion criteria (4 listed)
- Adult patient with organ failure requiring intubation for more than 48 hours
- In spontaneous ventilation with pressure support
- Presenting the common criteria of the unit to start a ventilatory weaning test
- Richmond Agitation Sedation Scale 0
Key exclusion criteria (4 listed)
- Sedated patient with a score of 0 at the Richmond Agitation Sedation Scale
- Pregnant woman
- Patient under guardianship or curators or deprived of public rights
- Patient with a contraindication to performing an external ultrasound
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 |
|---|---|---|
| Pulmonary Ultrasound2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation | Other | Extubation Failure, Extubation Success |
Primary outcome
Determine if pulmonary ultrasound observations are predictive factors linked with extubation failure
Time frame: 7 days
See if there's more pathological ultrasound signs in the extubation failure group
1 secondary outcome
Determine at wich range of pathological ultrasound observations there's a positive correlation with extubation failure
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
Damien DD DUCHEYRON, PHD principal investigator
University Hospital Center of Caen
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 Pulmonary Ultrasound and Weaning Failure, run by University Hospital, Caen 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 4 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 13 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien DD DUCHEYRON, PHD (+33231064716 ext. 4716, ducheyron-d@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if pulmonary ultrasound observations are predictive factors linked with extubation failure (time frame: 7 days). 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 13 Jul 2023.