Adult PatientsMORPHEITNCT03282331
Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)
A study testing Standard oxygenation, High flow nasal oxygenation and noninvasive ventilation in people with Adult Patients and Requiring Intubation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients. Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)
- What is being tested?
- Standard oxygenation, High flow nasal oxygenation and noninvasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2016to 1 Oct 2017
- 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
- • adults patients
- requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
- patient covered by french health care system
- patient included in Hopital Estaing, Clermont-Ferrand
Who cannot join
- • patient refusal
- intubation for other causes (excluding hypoxemia)
- impossibility to measure pulse oxymetry value
- contraindication for NIV : vomiting
- NIV intolerance
- cardiac arrest during intubation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
About this study
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Read the detailed description
Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit complications, ranging from desaturation, severe hypoxemia and bradycardia with potential cardiac arrest and death. International recommendations suggest the use of non-invasive ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently gained growing interest in the ICU as a treatment of acute respiratory failure, to improve extubation success and as a preoxygenation device before endotracheal intubation. Conflicting results have been published.
The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with valve bag mask for the preoxygenation before endotracheal intubation.
Investigator propose to add a lung morphology analysis during preoxygenation. Electrical impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via the evolution of local thoracic impedances with electrical loop circulating around a thoracic belt with electrodes.
The hypothesis is that the technique of preoxygenation might correlate with oxygen desaturation and potential intubation related complications (PREONIV study). Moreover lung morphology modifications evaluated by EIT might be associated with the preoxygenation technique (MORPHEIT study).
Investigator wish to asses lung morphological modifications evaluated by EIT during preoxygenation in a prospective non blinded randomized fashion.
- Conditions
- Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200), Patient Covered by French Health Care System
- Being tested
- Standard oxygenation, High flow nasal oxygenation, noninvasive ventilation
- Keywords
- Preoxygenation, Intubation, Electrical Impedance Tomography, Lung aeration, Alveolar recruitment
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard oxygenationProcedure or surgery
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
High flow nasal oxygenationProcedure or surgery
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
noninvasive ventilationProcedure or surgery
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
| Study group | Role | What they receive |
|---|---|---|
| standard oxygenation | Experimental | Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation Receives: Procedure: Standard oxygenation |
| High flow nasal oxygen therapy | Other | Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation Receives: Procedure: High flow nasal oxygenation |
| NonInvasive Ventilation | Other | Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation Receives: Procedure: noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation
Measured: at day 1
Secondary outcomes (9)
electrical impedance tomography related indexes
Measured: at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Lung inhomogeneity index
Measured: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
End expiratory lung impedance
Measured: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Center of Ventilation
Measured: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Tidal Volume
Measured: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
pulse oxymetry value
Measured: at day 1 (at 5 minutes and at 30 minutes after intubation)
Partial pressure of arterial oxygen (PaO2)
Measured: at day 1
Regurgitation rate
Measured: at day 1
oxyhemoglobin desaturation below 80 %
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 posted13 Sep 2017
- Study start2 Jun 2016
- Primary completion1 Sep 2017
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas GODET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282331
- Sponsor's protocol ID
- CHU-345
- Other IDs
- 2012-A00778-35
- Acronym
- MORPHEIT
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)
- ClinicalTrials.gov ID
- NCT03282331
- Acronym / sponsor ID
- MORPHEIT / CHU-345
- Conditions
- Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200), Patient Covered by French Health Care System
- Keywords
- Preoxygenation, Intubation, Electrical Impedance Tomography, Lung aeration, Alveolar recruitment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 13 Sep 2017 (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.
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Detailed description
Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit complications, ranging from desaturation, severe hypoxemia and bradycardia with potential cardiac arrest and death. International recommendations suggest the use of non-invasive ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently gained growing interest in the ICU as a treatment of acute respiratory failure, to improve extubation success and as a preoxygenation device before endotracheal intubation. Conflicting results have been published.
The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with valve bag mask for the preoxygenation before endotracheal intubation.
Investigator propose to add a lung morphology analysis during preoxygenation. Electrical impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via the evolution of local thoracic impedances with electrical loop circulating around a thoracic belt with electrodes.
The hypothesis is that the technique of preoxygenation might correlate with oxygen desaturation and potential intubation related complications (PREONIV study). Moreover lung morphology modifications evaluated by EIT might be associated with the preoxygenation technique (MORPHEIT study).
Investigator wish to asses lung morphological modifications evaluated by EIT during preoxygenation in a prospective non blinded randomized fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard oxygenation | Experimental | Procedure: Standard oxygenationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation |
| High flow nasal oxygen therapy | Other | Procedure: High flow nasal oxygenationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation |
| NonInvasive Ventilation | Other | Procedure: noninvasive ventilationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • adults patients
Key exclusion criteria (6 listed)
- • patient refusal
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 |
|---|---|---|
| Standard oxygenationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation | Procedure or surgery | standard oxygenation |
| High flow nasal oxygenationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation | Procedure or surgery | High flow nasal oxygen therapy |
| noninvasive ventilationElectrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation | Procedure or surgery | NonInvasive Ventilation |
Primary outcome
evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation
Time frame: at day 1
9 secondary outcomes
electrical impedance tomography related indexes
Time frame: at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Lung inhomogeneity index
Time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
End expiratory lung impedance
Time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Center of Ventilation
Time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Tidal Volume
Time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
pulse oxymetry value
Time frame: at day 1 (at 5 minutes and at 30 minutes after intubation)
Partial pressure of arterial oxygen (PaO2)
Time frame: at day 1
Regurgitation rate
Time frame: at day 1
oxyhemoglobin desaturation below 80 %
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 14 Sep 2017.
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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.
Thomas GODET 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?
A study testing Standard oxygenation, High flow nasal oxygenation and noninvasive ventilation in people with Adult Patients and Requiring Intubation, 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 4 inclusion and 6 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 14 Sep 2017. 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 (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation (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 14 Sep 2017.