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

Not Applicable

• Conditions: Respiratory Disease
• Interventions: Device: EIT

• Registration Number: NCT04180410
• Lead Sponsor: BioSerenity

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

Study Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Study Start: 2020-02-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21
• Primary Completion: 2021-08-19
• Study Completion: 2021-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
acute respiratory failure	48 hours	Occurrence of extubation failure

Secondary Outcome Measures

Name	Time	Method
pulmonary ventilation	48 hours	lung pulmonary volume (cm)

Trial Locations

Locations (1)

Aphp_La Pitie Salpetriere; 🇫🇷 Paris, France