- Critical CareNIVITNCT02150018
Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography
An observational study of - Critical Care and Non Invasive Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- - Critical Care, Non Invasive Ventilation, Electrical Impedance Tomography
- What is being tested?
- non invasive ventilation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2015
- Phase
- Observational
- 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
Study population: patients requiring non invasive ventilation
Who may be able to join
- Adult ICU patients requiring non invasive ventilation
- Consent of patients or family
- Arterial line
Who cannot join
- Tracheotomized patients
- Dressings in the thoracic area
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography
Read the detailed description
Prospective clinical study in ICU with patients requiring non invasive ventilation (NIV) comparing lung volumes determined by electrical impedance tomography before, during and after NIV.
Duration of NIV is 30 minutes.
- Conditions
- - Critical Care, Non Invasive Ventilation, Electrical Impedance Tomography, End Expiratory Lung Volume, End Expiratory Lung Impedance
- Being tested
- non invasive ventilation
- Keywords
- - Critical Care, Non invasive ventilation, Electrical impedance tomography, End expiratory lung volume, End expiratory lung impedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilationOther
| Study group | Role | What they receive |
|---|---|---|
| non invasive ventilation (NIV) | Not described Receives: Other: non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
- End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV
Measured: at day 1
Secondary outcomes (2)
Anterior, medio-anterior, medio-posterior and posterior EELV
Measured: at day 1
Ventilatory frequency
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for - Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing
- Responsible party
- Sponsor
- Investigators
- Sebastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150018
- Sponsor's protocol ID
- CHU-0193
- Acronym
- NIVIT
- Status last verified
- Jul 2015
- First submitted
- 26 May 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT02150018
- Acronym / sponsor ID
- NIVIT / CHU-0193
- Conditions
- - Critical Care, Non Invasive Ventilation, Electrical Impedance Tomography, End Expiratory Lung Volume, End Expiratory Lung Impedance
- Keywords
- - Critical Care, Non invasive ventilation, Electrical impedance tomography, End expiratory lung volume, End expiratory lung impedance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 May 2014 (estimated)
- 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.
Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography
Detailed description
Prospective clinical study in ICU with patients requiring non invasive ventilation (NIV) comparing lung volumes determined by electrical impedance tomography before, during and after NIV.
Duration of NIV is 30 minutes.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non invasive ventilation (NIV) | – | Other: non invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients requiring non invasive ventilation
Key inclusion criteria (3 listed)
- Adult ICU patients requiring non invasive ventilation
- Consent of patients or family
- Arterial line
Key exclusion criteria (2 listed)
- Tracheotomized patients
- Dressings in the thoracic area
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 |
|---|---|---|
| non invasive ventilation | Other | non invasive ventilation (NIV) |
Primary outcome
- End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV
Time frame: at day 1
2 secondary outcomes
Anterior, medio-anterior, medio-posterior and posterior EELV
Time frame: at day 1
Ventilatory frequency
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
Related trials for - Critical Care
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
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.
Sebastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of - Critical Care and Non Invasive Ventilation, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV (time frame: at day 1). 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 31 Jul 2015.