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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Damien DD DUCHEYRON, PHD contact

+33231064716 ext. 4716

ducheyron-d@chu-caen.fr

France1 site, 1 recruiting
  • University Hospital Center

    Caen, Calvados, 14000

    Damien Du Cheyron, PHD, 0231064716 ext. 4716, ducheyron-d@chu-caen.fr

    Arthur PLE, Intern

    Recruiting

Other trials in France

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 groups in NCT05944588
Study groupRoleWhat they receive
Extubation SuccessPatients who don't need a new intubation in the 7 days following the extubation
Receives: Other: Pulmonary Ultrasound
Extubation FailurePatients 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.

  1. 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)
  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.

  1. First posted13 Jul 2023
  2. Study start24 May 2023
  3. Primary completion22 May 2024 (estimated)
  4. Study completion22 May 2024 (estimated)

Resources

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
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

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.

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