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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04180410
Acronym
EXIT
Enrollment
60
Registered
2019-11-27
Start date
2020-02-15
Completion date
2021-08-19
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease

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

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.

Sponsors

BioSerenity
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

No-randomized,no-comparative study

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

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)

Design outcomes

Primary

MeasureTime frameDescription
acute respiratory failure48 hoursOccurrence of extubation failure

Secondary

MeasureTime frameDescription
pulmonary ventilation48 hourslung pulmonary volume (cm)

Countries

France

Contacts

Primary ContactEleonore CAILLET
eleonore.caillet@bioserenity.com0156092017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026