NCT04180410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

November 24, 2019

Last Update Submit

December 18, 2020

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

  • acute respiratory failure

    Occurrence of extubation failure

    48 hours

Secondary Outcomes (1)

  • pulmonary ventilation

    48 hours

Study Arms (1)

EIT

OTHER

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

Device: EIT

Interventions

EITDEVICE

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.

EIT

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age\> 65 years
  • Invasive mechanical ventilation time greater than 48 hours
  • known or suspected Chronic obstructive pulmonary disease
  • Known or suspected heart failure
  • Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
  • Patient or trusted person who has been informed of the study and has consented to participate

You may not qualify if:

  • Pregnant women, minor patients
  • Patients under extracorporeal circulatory assistance (ECMO)
  • Refusal of the patient
  • 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
  • Patients performing uncontrolled body movements
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aphp_La Pitie Salpetriere

Paris, 75013, France

RECRUITING

Related Publications (1)

  • Joussellin V, Bonny V, Spadaro S, Clerc S, Parfait M, Ferioli M, Sieye A, Jalil Y, Janiak V, Pinna A, Dres M. Lung aeration estimated by chest electrical impedance tomography and lung ultrasound during extubation. Ann Intensive Care. 2023 Sep 26;13(1):91. doi: 10.1186/s13613-023-01180-3.

    PMID: 37752365DERIVED

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Eleonore CAILLET

CONTACT

0156092017eleonore.caillet@bioserenity.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: No-randomized,no-comparative study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2019

First Posted

November 27, 2019

Study Start

February 15, 2020

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations

FR(1)