Critical CareIWEANNCT02361021
Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound
An observational study of Critical Care and Weaning From Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Weaning From Mechanical Ventilation, Electrical Impedance Tomography
- What is being tested?
- - Weaning from mechanical ventilation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Aug 2015
- 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: Adult ICU patients
Who may be able to join
- Adult ICU patients during weaning test from mechanical ventilation
- Consent of patients or family
- Arterial line
Who cannot join
- Tracheotomized patients
- Dressings in the thoracic area
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Sébastien PERBET
About this study
Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound
Read the detailed description
Prospective clinical study in ICU with patients during weaning from mechanical ventilation comparing lung aeration determined by electrical impedance tomography and lung ultrasound.
Duration of weaning test is 60 minutes.
- Conditions
- Critical Care, Weaning From Mechanical Ventilation, Electrical Impedance Tomography, End Expiratory Lung Volume, Lung Ultrasound Score
- Being tested
- - Weaning from mechanical ventilation
- Keywords
- Critical Care, Non invasive ventilation, Electrical impedance tomography, End expiratory lung volume, Lung ultrasound score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Weaning from mechanical ventilationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory lung volume (EELV)
End-expiratory lung volume (EELV) determined by electrical impedance tomography at baseline (start of the weaning test)
Measured: at baseline
End-expiratory lung volume (EELV)
- End-expiratory lung volume (EELV) determined by electrical impedance tomography at Hour 1 (end of the weaning test).
Measured: at hour 1
Secondary outcomes (4)
Anterior, medio-anterior, medio-posterior and posterior EELV
Measured: at baseline (start of the weaning test)
Lung ultrasound score
Measured: at baseline (start of the weaning test)
Anterior, medio-anterior, medio-posterior and posterior EELV
Measured: at Hour 1 (end of the weaning test)..
Lung ultrasound score
Measured: at Hour 1 (end of the weaning test)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
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.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361021
- Sponsor's protocol ID
- CHU-0222
- Acronym
- IWEAN
- Status last verified
- Jul 2015
- First submitted
- 2 Feb 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound
- ClinicalTrials.gov ID
- NCT02361021
- Acronym / sponsor ID
- IWEAN / CHU-0222
- Conditions
- Critical Care, Weaning From Mechanical Ventilation, Electrical Impedance Tomography, End Expiratory Lung Volume, Lung Ultrasound Score
- Keywords
- Critical Care, Non invasive ventilation, Electrical impedance tomography, End expiratory lung volume, Lung ultrasound score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Feb 2015 (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.
Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound
Detailed description
Prospective clinical study in ICU with patients during weaning from mechanical ventilation comparing lung aeration determined by electrical impedance tomography and lung ultrasound.
Duration of weaning test is 60 minutes.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients
Key inclusion criteria (3 listed)
- Adult ICU patients during weaning test from mechanical ventilation
- Consent of patients or family
- Arterial line
Key exclusion criteria (2 listed)
- Tracheotomized patients
- Dressings in the thoracic area
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 |
|---|---|---|
| - Weaning from mechanical ventilation | Other | – |
Primary outcome
End-expiratory lung volume (EELV)
Time frame: at baseline
End-expiratory lung volume (EELV) determined by electrical impedance tomography at baseline (start of the weaning test)
End-expiratory lung volume (EELV)
Time frame: at hour 1
- End-expiratory lung volume (EELV) determined by electrical impedance tomography at Hour 1 (end of the weaning test).
4 secondary outcomes
Anterior, medio-anterior, medio-posterior and posterior EELV
Time frame: at baseline (start of the weaning test)
Lung ultrasound score
Time frame: at baseline (start of the weaning test)
Anterior, medio-anterior, medio-posterior and posterior EELV
Time frame: at Hour 1 (end of the weaning test)..
Lung ultrasound score
Time frame: at Hour 1 (end of the weaning test)..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
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 From 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 3 inclusion and 2 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 24 Jul 2015. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-expiratory lung volume (EELV) (time frame: at baseline). The study lists 2 primary outcomes in all. 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 24 Jul 2015.