ClinicalTrials.gg
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has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.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

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03

In context

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

This study's planned enrollment of 60 is below the median of 69 across 216 interventional studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

BioSerenity is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age> 65 years
  2. Invasive mechanical ventilation time greater than 48 hours
  3. known or suspected
  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. 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.
    • (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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • Aphp_La Pitie Salpetriere
    Paris, 75013, France
    Recruiting
    • MARTIN DRES, DR · Contact
    • MARTIN DRES, DR · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2020 (actual). Primary completion is estimated for Aug 2021, 18 months after the start.

Of 111 interventional studies with no phase under Respiration Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 18 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2019
First posted
Nov 27, 2019
StartActual
Feb 15, 2020
Primary completionEst.
Aug 19, 2021
CompletionEst.
Aug 19, 2021
Last update
Dec 21, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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