Back to resultsMonitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation (EXIT)
Primary Purpose
Respiratory Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EIT
Sponsored by
About this trial
This is an interventional other trial for Respiratory Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 ...
- 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)
Sites / Locations
- Aphp_La Pitie SalpetriereRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EIT
Arm Description
Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation
Outcomes
Primary Outcome Measures
acute respiratory failure
Occurrence of extubation failure
Secondary Outcome Measures
pulmonary ventilation
lung pulmonary volume (cm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04180410
Brief Title
Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
Acronym
EXIT
Official Title
Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
August 19, 2021 (Anticipated)
Study Completion Date
August 19, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioSerenity
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
No-randomized,no-comparative study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EIT
Arm Type
Other
Arm Description
Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation
Intervention Type
Device
Intervention Name(s)
EIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
acute respiratory failure
Description
Occurrence of extubation failure
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
pulmonary ventilation
Description
lung pulmonary volume (cm)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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 ...
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleonore CAILLET
Phone
0156092017
Email
eleonore.caillet@bioserenity.com
Facility Information:
Facility Name
Aphp_La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARTIN DRES, DR
First Name & Middle Initial & Last Name & Degree
MARTIN DRES, DR
12. IPD Sharing Statement
Learn more about this trial
Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
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