- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077605
Effect of Extubation on Respiratory Function (PULMOVISTA)
Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Var
-
Toulon, Var, France, 83100
- Hôpital d'Instruction des Armées de Sainte Anne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Functional residual capacity
Functional residual capacity measure during and after extubation
|
Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
End Expiratory Lung Impedance (EELI)
Time Frame: Between 2 and 3 hours
|
EELI variation before and at different timepoints after extubation: T0, T5, T10, T15 and T20 (min).
|
Between 2 and 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tidal volume distribution
Time Frame: 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).
|
Between 2 and 3 hours
|
|
Tidal volume distribution depending on patient position
Time Frame: Between 2 and 3 hours
|
Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus
|
Between 2 and 3 hours
|
|
Tidal volume distribution depending on surgery type and duration
Time Frame: Between 2 and 3 hours
|
Percentage of tidal volume according to type and duration of surgery
|
Between 2 and 3 hours
|
|
Tidal volume distribution depending on ventilatory mode
Time Frame: 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
|
Between 2 and 3 hours
|
Collaborators and Investigators
Investigators
- Study Director: Clarisse LEGER, Nurse, Hôpital d'instruction des armées Sainte-Anne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-CHITS-001
- 2021-A00785-36 (Other Identifier: Id RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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