Effect of Extubation on Respiratory Function

Functional Residual Capacity Clinical Trial

— PULMOVISTA  

Official title:

Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077605
• Other study ID #: 2020-CHITS-001
• Secondary ID: 2021-A00785-36
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Residual Capacity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées de Sainte Anne	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tidal volume distribution	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
Secondary	Tidal volume distribution depending on patient position	Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus	Between 2 and 3 hours
Secondary	Tidal volume distribution depending on surgery type and duration	Percentage of tidal volume according to type and duration of surgery	Between 2 and 3 hours
Secondary	Tidal volume distribution depending on ventilatory mode	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