ARDSREPEITNCT06541522
Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS
A study testing EIT in people with ARDS, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
Trial summary
ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- EIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
- Criteria for moderate to severe ARDS for less than 72 hours
- Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
- Consent of next of kin
Who cannot join
- Age < 18 years
- ECMO
- Pneumothorax
- Pacemaker or implantable defibrillator
- Chest trauma in the last 3 months
- Skin peeling (Burned, Lyell)
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- Intracranial hypertension
- Uncontrolled shock (noradrenaline >5 mg/h)
- Pregnant woman
- Adult patient protected within the meaning of the law
- Lack of social security
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Belt Position on the Results of PEEP Titration by Electrical Impedance Tomography During Acute Respiratory Distress Syndrome
ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.
Read the detailed description
The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.
- Conditions
- ARDS
- Being tested
- EIT
- Keywords
- ARDS, mechanical ventilation, EIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EITDevice
Two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height (2nd intercostal space or 5th intercostal space). The order will be drawn at random.
| Study group | Role | What they receive |
|---|---|---|
| PEEP titrations | Other | Not described Receives: Device: EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the position of the electrode belt on the results of PEEP titration by EIT.
Optimal PEEP determined by PEEP titration using the crossing point method.
Measured: Day 0
Secondary outcomes (3)
Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS
Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median
Measured: Day 0
Factors associated with a discordance between PEPEIT and PEPCRS
Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median
Measured: Day 0
Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume
Regional ventilation delay (RVD)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Once the patient is included in the research, two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height. The order will be drawn at random.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541522
- Sponsor's protocol ID
- REPEIT
- Acronym
- REPEIT
- Status last verified
- Nov 2024
- First submitted
- 30 Jul 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Belt Position on the Results of PEEP Titration by Electrical Impedance Tomography During Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06541522
- Acronym / sponsor ID
- REPEIT / REPEIT
- Conditions
- ARDS
- Keywords
- ARDS, mechanical ventilation, EIT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 7 Aug 2024 (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.
ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.
Detailed description
The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Once the patient is included in the research, two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height. The order will be drawn at random.
| Arm | Type | Receives |
|---|---|---|
| PEEP titrations | Other | Device: EIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
- Criteria for moderate to severe ARDS for less than 72 hours
- Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
- Consent of next of kin
Key exclusion criteria (11 listed)
- Age < 18 years
- ECMO
- Pneumothorax
- Pacemaker or implantable defibrillator
- Chest trauma in the last 3 months
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 |
|---|---|---|
| EITTwo PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height (2nd intercostal space or 5th intercostal space). The order will be drawn at random. | Device | PEEP titrations |
Primary outcome
Impact of the position of the electrode belt on the results of PEEP titration by EIT.
Time frame: Day 0
Optimal PEEP determined by PEEP titration using the crossing point method.
3 secondary outcomes
Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS
Time frame: Day 0
Factors associated with a discordance between PEPEIT and PEPCRS
Time frame: Day 0
Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EIT in people with ARDS, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
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 11 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Tuffet, MD (+33(0)478618209, stuffet@saintjosephsaintluc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the position of the electrode belt on the results of PEEP titration by EIT. (time frame: Day 0). 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 21 Nov 2024.