Effect of Extubation on Respiratory Function

NCT ID: NCT05077605

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2022-06-30

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.

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.

Conditions

Functional Residual Capacity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Functional residual capacity

Functional residual capacity measure during and after extubation

Group Type: EXPERIMENTAL

Functional residual capacity measure by electrical impedance tomography

Intervention Type: OTHER

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

Interventions

Functional residual capacity measure by electrical impedance tomography

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarisse LEGER, Nurse

Role: STUDY_DIRECTOR

Hôpital d'instruction des armées Sainte-Anne

Locations

Hôpital d'Instruction des Armées de Sainte Anne

Toulon, Var, France

Countries

France

Other Identifiers

2021-A00785-36

Identifier Type: OTHER

Identifier Source: secondary_id

2020-CHITS-001

Identifier Type: -

Identifier Source: org_study_id