Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation

NCT ID: NCT04180410

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2021-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

No-randomized,no-comparative study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EIT

Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation

Group Type OTHER

EIT

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EIT

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age\> 65 years
2. Invasive mechanical ventilation time greater than 48 hours
3. known or suspected Chronic obstructive pulmonary disease
4. Known or suspected heart failure
5. Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
6. Patient or trusted person who has been informed of the study and has consented to participate

Exclusion Criteria

1. Pregnant women, minor patients
2. Patients under extracorporeal circulatory assistance (ECMO)
3. Refusal of the patient
4. Contraindications to the realization of the phrenic nerve stimulation technique:

* Pacemaker, implantable cardiac defibrillator and other pacemakers
* Spinal implants, thoracic drains ...
* Copper allergy
* Epileptic patients
5. Patients performing uncontrolled body movements
6. 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
7. Patients under legal protection (tutorship / guardianship)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioSerenity

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aphp_La Pitie Salpetriere

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eleonore CAILLET

Role: CONTACT

Phone: 0156092017

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MARTIN DRES, DR

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37752365 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A02986-51

Identifier Type: -

Identifier Source: org_study_id