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Status unknownNCT04180410EXITUpdated Dec 21, 2020

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

An interventional study of EIT in Respiratory Disease, sponsored by BioSerenity. Status unknown at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by BioSerenity · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Respiratory Disease
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    EIT

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

    Device: EIT

Interventions

  • DeviceEIT

    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.

05

What researchers measure

Primary outcomes

  1. acute respiratory failure

    Occurrence of extubation failure

    Time frame: 48 hours

Secondary outcomes

  1. pulmonary ventilation

    lung pulmonary volume (cm)

    Time frame: 48 hours

06

Study locations

1 of 1 sites recruiting
  • Aphp_La Pitie Salpetriere
    Paris, 75013, France
    • MARTIN DRES, DR · Contact
    • MARTIN DRES, DR · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT04180410
Lead sponsor
BioSerenity
Responsible party
Sponsor
First posted
Nov 27, 2019
Start date
Feb 15, 2020
Primary completion
Aug 19, 2021 (estimated)
Completion
Aug 19, 2021 (estimated)
Last update
Dec 21, 2020

Study contacts

Eleonore CAILLET
Contact
eleonore.caillet@bioserenity.com
0156092017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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