NCT05077605

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

October 1, 2021

Last Update Submit

April 10, 2026

Conditions

Keywords

ExtubationFunctional residual capacityElectrical impedance tomographyPulmovistaRespiratory function

Outcome Measures

Primary Outcomes (1)

  • End Expiratory Lung Impedance (EELI)

    EELI variation before and at different timepoints after extubation: T0, T5, T10, T15 and T20 (min).

    Between 2 and 3 hours

Secondary Outcomes (4)

  • Tidal volume distribution

    Between 2 and 3 hours

  • Tidal volume distribution depending on patient position

    Between 2 and 3 hours

  • Tidal volume distribution depending on surgery type and duration

    Between 2 and 3 hours

  • Tidal volume distribution depending on ventilatory mode

    Between 2 and 3 hours

Study Arms (1)

Functional residual capacity

EXPERIMENTAL

Functional residual capacity measure during and after extubation

Other: Functional residual capacity measure by electrical impedance tomography

Interventions

Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.

Functional residual capacity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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...)
  • Any other reason that, in the opinion of the investigator, could interfere with the evaluation of study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital d'Instruction des Armées de Sainte Anne

Toulon, Var, 83100, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clarisse LEGER, Nurse

    Hôpital d'instruction des armées Sainte-Anne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 14, 2021

Study Start

November 5, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations