Critical CareCARWEANNCT02138903
A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial
An observational study of Critical Care and Weaning of Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Weaning of Mechanical Ventilation, Trans-thoracic Echocardiography
- What is being tested?
- trans thoracic echocardiography
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Nov 2014
- 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
Who may be able to join
- Adult patients ventilated requiring first weaning trial of mechanical ventilation
- Stable respiratory and hemodynamic conditions
- Consent of patients or family
- Arterial line
- Ventilated patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.
Read the detailed description
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.
- Conditions
- Critical Care, Weaning of Mechanical Ventilation, Trans-thoracic Echocardiography, Mitral Doppler, Diastolic Function
- Being tested
- trans thoracic echocardiography
- Keywords
- weaning, Cardiac, Echocardiography, Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans thoracic echocardiographyOther
| Study group | Role | What they receive |
|---|---|---|
| ZEEP and tubing-spontaneous ventilation | Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. Receives: Other: trans thoracic echocardiography | |
| trans-thoracic echocardiography | Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. Receives: Other: trans thoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular filling pressure
Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed
Measured: after 1 hour
Secondary outcomes (1)
Comparison of other echocardiographic parameters of left ventricular filling pressures
Comparison of other echocardiographic parameters of left ventricular filling pressures (E, Ea, deceleration time) at the end of weaning trial
Measured: after 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138903
- Sponsor's protocol ID
- CHU-189
- Other IDs
- 2013-000960-26
- Acronym
- CARWEAN
- Status last verified
- Nov 2014
- First submitted
- 11 Apr 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial
- ClinicalTrials.gov ID
- NCT02138903
- Acronym / sponsor ID
- CARWEAN / CHU-189
- Conditions
- Critical Care, Weaning of Mechanical Ventilation, Trans-thoracic Echocardiography, Mitral Doppler, Diastolic Function
- Keywords
- weaning, Cardiac, Echocardiography, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 May 2014 (estimated)
- 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.
Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.
Detailed description
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEEP and tubing-spontaneous ventilation | – | Other: trans thoracic echocardiographyProspective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. |
| trans-thoracic echocardiography | – | Other: trans thoracic echocardiographyProspective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (5 listed)
- Adult patients ventilated requiring first weaning trial of mechanical ventilation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| trans thoracic echocardiography | Other | ZEEP and tubing-spontaneous ventilation, trans-thoracic echocardiography |
Primary outcome
left ventricular filling pressure
Time frame: after 1 hour
Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed
1 secondary outcome
Comparison of other echocardiographic parameters of left ventricular filling pressures
Time frame: after 1 hour
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 2 Dec 2014.
Related trials for Critical Care
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
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 Critical Care and Weaning of Mechanical Ventilation, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 1 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 2 Dec 2014. 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?
left ventricular filling pressure (time frame: after 1 hour). 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 2 Dec 2014.