Effect of Extubation on Respiratory Function (PULMOVISTA)

Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity

The extubation phase is a risky period of anesthesia management. During this step, serious complications can arise: hypoxemia, laryngospasm, pharyngeal obstruction, pneumonia… In spite of these complications, extubation and its impact on respiratory function, particularly on the Functional Residual Capacity (FRC), remains poorly studied because of the difficulty to make bedside measurements.

The PulmoVista 500 is a clinical routine which provide effective non-invasive bedside measurements. It would be interesting to evaluate the impact of extubation on respiratory function, and more specifically FRC changes during and after extubation.

This study will allow a better physiopathological knowledge and a quality improvement patient extubation management.

Study Overview

Detailed Description

The aim of this study is to evaluate the variation of functional residual capacity and its distribution before and after extubation.

Patients with scheduled surgery and receiving general anesthesia with orotracheal intubation are included and the measurements will be performed in the post-interventional monitoring room (PICU). EELI data will be collected before extubation and then at T0, then T5, T10, T15 and T20 minutes. No subsequent follow-up is required.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Var
      • Toulon, Var, France, 83100
        • Hôpital d'Instruction des Armées de Sainte Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years
  • Patient in operating room for scheduled surgery
  • Patient receiving general anaesthesia with orotracheal intubation
  • Patient given written consent after information
  • Patient covered by social security or equivalent regimen

Exclusion Criteria:

  • Patient undergoing thoracic and spinal surgery, due to the presence of dressings that interfere with measurements,
  • Patient who has undergone intracerebral surgery because of possible communication difficulties upon awakening,
  • Patients with a body mass index (BMI) > 50 (measurements not possible)
  • Pregnant or breastfeeding patient,
  • Patient contraindicated to the use of a thoracic electroimpedancemetry technique: dressings, wounds, presence of a pacemaker, defibrillator or any other active implant.
  • Patient deprived of liberty by a judicial or administrative decision or patient subject to a legal protection measure (guardianship, curatorship...)
  • Patient in a period of exclusion from another research protocol
  • Any other reason that, in the opinion of the investigator, could interfere with the evaluation of study objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional residual capacity
Functional residual capacity measure during and after extubation
Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End Expiratory Lung Impedance (EELI)
Time Frame: Between 2 and 3 hours
EELI variation before and at different timepoints after extubation: T0, T5, T10, T15 and T20 (min).
Between 2 and 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal volume distribution
Time Frame: Between 2 and 3 hours
Percentage of tidal volume in the different regions of interest before extubation and at different timepoints after it: T0, T5, T10, T15 and T20 (min).
Between 2 and 3 hours
Tidal volume distribution depending on patient position
Time Frame: Between 2 and 3 hours
Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus
Between 2 and 3 hours
Tidal volume distribution depending on surgery type and duration
Time Frame: Between 2 and 3 hours
Percentage of tidal volume according to type and duration of surgery
Between 2 and 3 hours
Tidal volume distribution depending on ventilatory mode
Time Frame: Between 2 and 3 hours
Percentage of tidal volume according to the ventilatory mode: controlled ventilation, spontaneous ventilation with inspiratory assistance, spontaneous ventilation of extubated patient with or without oxygenation device
Between 2 and 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clarisse LEGER, Nurse, Hôpital d'instruction des armées Sainte-Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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