Functional Residual CapacityPULMOVISTANCT05077605
Effect of Extubation on Respiratory Function
A study testing Functional residual capacity measure by electrical impedance tomography in people with Functional Residual Capacity, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Residual Capacity
- What is being tested?
- Functional residual capacity measure by electrical impedance tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital d'Instruction des Armées de Sainte Anne
Toulon, Var, 83100
About this study
Official title: 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.
Read the 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
- Being tested
- Functional residual capacity measure by electrical impedance tomography
- Keywords
- Extubation, Functional residual capacity, Electrical impedance tomography, Pulmovista, Respiratory function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional residual capacity measure by electrical impedance tomographyOther
Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.
| Study group | Role | What they receive |
|---|---|---|
| Functional residual capacity | Experimental | Functional residual capacity measure during and after extubation Receives: Other: Functional residual capacity measure by electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Expiratory Lung Impedance (EELI)
EELI variation before and at different timepoints after extubation: T0, T5, T10, T15 and T20 (min).
Measured: Between 2 and 3 hours
Secondary outcomes (4)
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).
Measured: Between 2 and 3 hours
Tidal volume distribution depending on patient position
Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus
Measured: Between 2 and 3 hours
Tidal volume distribution depending on surgery type and duration
Percentage of tidal volume according to type and duration of surgery
Measured: Between 2 and 3 hours
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
Measured: Between 2 and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start5 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Residual CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisse LEGER, Nurse, Study director, Hôpital d'instruction des armées Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077605
- Sponsor's protocol ID
- 2020-CHITS-001
- Other IDs
- 2021-A00785-36
- Acronym
- PULMOVISTA
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity
- ClinicalTrials.gov ID
- NCT05077605
- Acronym / sponsor ID
- PULMOVISTA / 2020-CHITS-001
- Conditions
- Functional Residual Capacity
- Keywords
- Extubation, Functional residual capacity, Electrical impedance tomography, Pulmovista, Respiratory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional residual capacity | Experimental | Other: Functional residual capacity measure by electrical impedance tomographyFunctional residual capacity measure during and after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional residual capacity measure by electrical impedance tomographyPatient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation. | Other | Functional residual capacity |
Primary outcome
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).
4 secondary outcomes
Tidal volume distribution
Time frame: Between 2 and 3 hours
Tidal volume distribution depending on patient position
Time frame: Between 2 and 3 hours
Tidal volume distribution depending on surgery type and duration
Time frame: Between 2 and 3 hours
Tidal volume distribution depending on ventilatory mode
Time frame: Between 2 and 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarisse LEGER, Nurse study director
Hôpital d'instruction des armées Sainte-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional residual capacity measure by electrical impedance tomography in people with Functional Residual Capacity, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End Expiratory Lung Impedance (EELI) (time frame: Between 2 and 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.