Respiratory DiseaseEXITNCT04180410
Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
A study testing EIT in people with Respiratory Disease, run by BioSerenity at 1 site in France.
Trial summary
The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- EIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2020to 19 Aug 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age> 65 years
- Invasive mechanical ventilation time greater than 48 hours
- known or suspected Chronic obstructive pulmonary disease
- Known or suspected heart failure
- Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
- Patient or trusted person who has been informed of the study and has consented to participate
Who cannot join
- Pregnant women, minor patients
- Patients under extracorporeal circulatory assistance (ECMO)
- Refusal of the patient
- Contraindications to the realization of the phrenic nerve stimulation technique:
- Pacemaker, implantable cardiac defibrillator and other pacemakers
- Spinal implants, thoracic drains ...
Show all 17Show fewer
- Copper allergy
- Epileptic patients
- Patients performing uncontrolled body movements
- Contraindications to the realization of the technique of Electrical Imaging Tomography:
- Breast circumference not between 70 cm and 150 cm.
- Body mass index (BMI) greater than 50
- Impossibility of placing the CT belt at the level of the chest skin (lesions, bandages, dressings, chest drains ...)
- Patients with unstable spinal lesions or fractures
- Allergy to tomography belt materials: silicone, brass, stainless steel
- Pacemaker, implantable cardiac defibrillator and other pacemakers
- Patients under legal protection (tutorship / guardianship)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Aphp_La Pitie Salpetriere
Paris, 75013
MARTIN DRES, DR
MARTIN DRES, DR
About this study
The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.
Read the detailed description
The aim is to follow the patients after extubation for the lung description.
EIT exam is performed before extubation, during follow-up visits and 48H after extubation
- Conditions
- Respiratory Disease
- Being tested
- EIT
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EITDevice
Electrical Impedance Tomography is performed before extubation, during follow-up visits of extubation and 48H after extubation. Follow-up visits are shortened in case of extubation failure.
| Study group | Role | What they receive |
|---|---|---|
| EIT | Other | Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation Receives: Device: EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute respiratory failure
Occurrence of extubation failure
Measured: 48 hours
Secondary outcomes (1)
pulmonary ventilation
lung pulmonary volume (cm)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start15 Feb 2020
- Primary completion19 Aug 2021 (estimated)
- Study completion19 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No-randomized,no-comparative study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180410
- Sponsor's protocol ID
- 2019-A02986-51
- Acronym
- EXIT
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joussellin V, Bonny V, Spadaro S, Clerc S, Parfait M, Ferioli M, Sieye A, Jalil Y, Janiak V, Pinna A, Dres M. Lung aeration estimated by chest electrical impedance tomography and lung ultrasound during extubation. Ann Intensive Care. 2023 Sep 26;13(1):91. doi: 10.1186/s13613-023-01180-3.
PubMed 37752365
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
- ClinicalTrials.gov ID
- NCT04180410
- Acronym / sponsor ID
- EXIT / 2019-A02986-51
- Conditions
- Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 19 Aug 2021 (estimated)
- Study completion
- 19 Aug 2021 (estimated)
- First posted
- 27 Nov 2019 (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 Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.
Detailed description
The aim is to follow the patients after extubation for the lung description.
EIT exam is performed before extubation, during follow-up visits and 48H after extubation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No-randomized,no-comparative study
| Arm | Type | Receives |
|---|---|---|
| EIT | Other | Device: EITElectrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age> 65 years
- Invasive mechanical ventilation time greater than 48 hours
- known or suspected Chronic obstructive pulmonary disease
- Known or suspected heart failure
- Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
Key exclusion criteria (17 listed)
- Pregnant women, minor patients
- Patients under extracorporeal circulatory assistance (ECMO)
- Refusal of the patient
- Contraindications to the realization of the phrenic nerve stimulation technique:
- Patients performing uncontrolled body movements
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 |
|---|---|---|
| EITElectrical Impedance Tomography is performed before extubation, during follow-up visits of extubation and 48H after extubation. Follow-up visits are shortened in case of extubation failure. | Device | EIT |
Primary outcome
acute respiratory failure
Time frame: 48 hours
Occurrence of extubation failure
1 secondary outcome
pulmonary ventilation
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 37752365Joussellin V, Bonny V, Spadaro S, Clerc S, Parfait M, Ferioli M, Sieye A, Jalil Y, Janiak V, Pinna A, Dres M. Lung aeration estimated by chest electrical impedance tomography and lung ultrasound during extubation. Ann Intensive Care. 2023 Sep 26;13(1):91. doi: 10.1186/s13613-023-01180-3.
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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?
A study testing EIT in people with Respiratory Disease, run by BioSerenity 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 6 inclusion and 17 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 21 Dec 2020. 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 Eleonore CAILLET (0156092017, eleonore.caillet@bioserenity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute respiratory failure (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180410, which also lists 1 linked publication.
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 21 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.