Effect of Extubation on Respiratory Function

Not Applicable

Completed

• Conditions: Functional Residual Capacity
• Interventions: Other: Functional residual capacity measure by electrical impedance tomography

• Registration Number: NCT05077605
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Study Start: 2021-11-05
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional residual capacity	Functional residual capacity measure by electrical impedance tomography	Functional residual capacity measure during and after extubation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tidal volume distribution depending on patient position	Between 2 and 3 hours	Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus
Tidal volume distribution	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).
Tidal volume distribution depending on surgery type and duration	Between 2 and 3 hours	Percentage of tidal volume according to type and duration of surgery
Tidal volume distribution depending on ventilatory mode	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

Trial Locations

Locations (1)

Hôpital d'Instruction des Armées de Sainte Anne; 🇫🇷 Toulon, Var, France