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

Respiratory Disease Clinical Trial

— EXIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180410
• Other study ID #: 2019-A02986-51
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: August 19, 2021

Study information

• Verified date: December 2020
• Source: BioSerenity
• Contact: Eleonore CAILLET
• Phone: 0156092017
• Email: eleonore.caillet[@]bioserenity.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 19, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Aphp_La Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BioSerenity

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute respiratory failure	Occurrence of extubation failure	48 hours
Secondary	pulmonary ventilation	lung pulmonary volume (cm)	48 hours