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

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BioSerenity

Status

Unknown

Conditions

Respiratory Disease

Treatments

Device: EIT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04180410
2019-A02986-51

Details and patient eligibility

About

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.

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

EIT
Other group
Description:
Electrical Impedance Tomography is performed before extubation, during follow up visits of extubation and 48H after extubation
Treatment:
Device: EIT

Trial contacts and locations

1

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Central trial contact

Eleonore CAILLET

Data sourced from clinicaltrials.gov

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