Critical CareOXIDIANCT02186288
Effect of High-flow Nasal Cannula Oxygen on Lung Volumes Determined by Electrical Impedance Tomography
An observational study of Critical Care and High-flow Nasal Cannula Oxygen, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Effect of High-flow nasal cannula oxygen 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, High-flow Nasal Cannula Oxygen, Electrical Impedance Tomography
- What is being tested?
- High-flow nasal cannula oxygen
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Oct 2014
- 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: Adult ICU patients
Who may be able to join
- • Adult ICU patients requiring High-flow nasal cannula oxygen
- 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.
About this study
Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by electrical impedance tomography
Read the detailed description
Prospective clinical study in ICU with patients requiring High-flow nasal cannula oxygen comparing lung volumes determined by electrical impedance tomography and diaphragmatic ultrasound before, during and after High-flow nasal cannula oxygen.
Duration of High-flow nasal cannula oxygen is 30 minutes.
- Conditions
- Critical Care, High-flow Nasal Cannula Oxygen, Electrical Impedance Tomography, End Expiratory Lung Volume, End Expiratory Lung Impedance, Diaphragmatic Ultrasound
- Being tested
- High-flow nasal cannula oxygen
- Keywords
- Critical Care, High-flow nasal cannula oxygen, Electrical impedance tomography, End expiratory lung volume, End expiratory lung impedance, Diaphragmatic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula oxygenOther
| Study group | Role | What they receive |
|---|---|---|
| Adult ICU patients | Not described Receives: Other: High-flow nasal cannula oxygen |
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 NIV non invasive ventilation
Measured: at day 1
End-expiratory lung volume (EELV) determined by electrical impedance tomography during NIV non invasive ventilation
Measured: at day 1
End-expiratory lung volume (EELV) determined by electrical impedance tomography after NIV non invasive ventilation
Measured: at day 1
Secondary outcomes (3)
Anterior, medio-anterior, medio-posterior and posterior EELV at each time
Measured: at day 1
Diaphragmatic excursion and thickness determined by ultrasound
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 posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186288
- Sponsor's protocol ID
- CHU-0196
- Acronym
- OXIDIA
- Status last verified
- Jul 2015
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-flow Nasal Cannula Oxygen on Lung Volumes Determined by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT02186288
- Acronym / sponsor ID
- OXIDIA / CHU-0196
- Conditions
- Critical Care, High-flow Nasal Cannula Oxygen, Electrical Impedance Tomography, End Expiratory Lung Volume, End Expiratory Lung Impedance, Diaphragmatic Ultrasound
- Keywords
- Critical Care, High-flow nasal cannula oxygen, Electrical impedance tomography, End expiratory lung volume, End expiratory lung impedance, Diaphragmatic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jul 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 High-flow nasal cannula oxygen on end-expiratory lung volumes determined by electrical impedance tomography
Detailed description
Prospective clinical study in ICU with patients requiring High-flow nasal cannula oxygen comparing lung volumes determined by electrical impedance tomography and diaphragmatic ultrasound before, during and after High-flow nasal cannula oxygen.
Duration of High-flow nasal cannula oxygen is 30 minutes.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU patients | – | Other: High-flow nasal cannula oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients
Key inclusion criteria (3 listed)
- • Adult ICU patients requiring High-flow nasal cannula oxygen
Key exclusion criteria (2 listed)
- • Tracheotomized patients
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 |
|---|---|---|
| High-flow nasal cannula oxygen | Other | Adult ICU patients |
Primary outcome
End-expiratory lung volume (EELV) determined by electrical impedance tomography before NIV non invasive ventilation
Time frame: at day 1
End-expiratory lung volume (EELV) determined by electrical impedance tomography during NIV non invasive ventilation
Time frame: at day 1
End-expiratory lung volume (EELV) determined by electrical impedance tomography after NIV non invasive ventilation
Time frame: at day 1
3 secondary outcomes
Anterior, medio-anterior, medio-posterior and posterior EELV at each time
Time frame: at day 1
Diaphragmatic excursion and thickness determined by ultrasound
Time frame: at day 1
Ventilatory frequency
Time frame: at day 1
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 24 Jul 2015.
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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.
Sébastien 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 High-flow Nasal Cannula Oxygen, 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: finished, as of the sponsor's last update on 24 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?
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 volume (EELV) determined by electrical impedance tomography before NIV non invasive ventilation (time frame: at day 1). The study lists 3 primary outcomes in all. 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 24 Jul 2015.