Clinical trial NCT05077605: Effect of Extubation on Respiratory Function
Official title: Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Residual Capacity
Keywords: Extubation
Functional residual capacity
Electrical impedance tomography
Pulmovista
Respiratory function
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: End Expiratory Lung Impedance (EELI)
timeFrame: Between 2 and 3 hours
Secondary outcomes:
measure: Tidal volume distribution
timeFrame: Between 2 and 3 hours
measure: Tidal volume distribution depending on patient position
timeFrame: Between 2 and 3 hours
measure: Tidal volume distribution depending on surgery type and duration
timeFrame: Between 2 and 3 hours
measure: Tidal volume distribution depending on ventilatory mode
timeFrame: Between 2 and 3 hours
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées de Sainte Anne
state: Var
Study officials:
affiliation: Hôpital d'instruction des armées Sainte-Anne
name: Clarisse LEGER, Nurse
role: STUDY_DIRECTOR
References: