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

December 18, 2020 updated by: BioSerenity
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Aphp_La Pitie Salpetriere
        • Principal Investigator:
          • Martin DRES, Dr
        • Contact:
          • MARTIN DRES, DR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: EIT
Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute respiratory failure
Time Frame: 48 hours
Occurrence of extubation failure
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary ventilation
Time Frame: 48 hours
lung pulmonary volume (cm)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSerenity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2020

Primary Completion (ANTICIPATED)

August 19, 2021

Study Completion (ANTICIPATED)

August 19, 2021

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (ACTUAL)

November 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02986-51

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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