ARDS (Acute Respiratory Distress Syndrome)TICTACNCT07623590
Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography
A study testing PEEP titrations in people with ARDS (Acute Respiratory Distress Syndrome), run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 2 sites in France.
Trial summary
Patients with acute respiratory distress syndrome are placed on mechanical ventilation, and the adjustment of ventilator parameters is an important step in their care, in particular positive expiratory pressure, applied at the end of breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- PEEP titrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Apr 2025to 5 May 2027
- 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
- Age ≥ 18 years
- Moderate to severe ARDS according to the Berlin criteria
- Patient receiving sedation and continuous curarization
- Free and informed consent from the patient or their loved one
Who cannot join
- ECMO
- Pneumothorax
- Chest trauma in the last 3 months
- Uncontrolled shock (noradrenaline > 5 mg/h)
- Pregnant or breastfeeding woman
- Protected adult within the meaning of the law
- Lack of social security
- Patient under AME
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fanny Doroszewski, Mrs contact
France2 sites, 2 recruiting
- Recruiting
GHU Henri Mondor
Créteil, 94000
Guillaume Carteaux, Pr, +33149812111, guillaume.carteaux@aphp.fr
Guillaume Carteaux, Pr
- Recruiting
Hôpital Saint Joseph Saint Luc
Lyon, 69007
Emmanuel Vivier, Dr, +33478618209, evivier@saintjosephsaintluc.fr
Fanny Doroszewski, +33478618398, fdoroszewski@saintjosephsaintluc.fr
About this study
Patients with acute respiratory distress syndrome are placed on mechanical ventilation, and the adjustment of ventilator parameters is an important step in their care, in particular positive expiratory pressure, applied at the end of breathing.
The goal of this study is to learn if continuous anterior chest compression works as well as electrical impedance tomography for positive expiratory pressure titration.
Researchers will compare the two methods for each patient, in a randomly determined order : continuous anterior chest compression and electrical impedance tomography.
Participants will :
- have a pep titration with both techniques
- be included in the study for 28 days
Read the detailed description
Personalizing the PEEP level is an important step in ventilator adjustment in ARDS patients.
The investigators have developed a simple, low-cost method to detect overdistension of the lung, consisting of applying manual compression to the anterior aspect of the patient's thorax, and observing whether the ventilator pressure increases or decreases.
The investigators hypothesize that with this simple method it is possible to determine the PEEP level which corresponds to that determined with EIT.
- Being tested
- PEEP titrations
- Keywords
- EIT, ARDS, PEEP
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP titrationsOther
Assessment of ideal PEEP using electrical impedance tomography will be performed. The evaluation of PEEP using the thorax compression maneuver method will be carried out. A blood sample (the "blood gases") will be taken at the ideal PEEP determined by electrical impedance tomography and at the ideal PEEP determined by the manual chest compression maneuver.
| Study group | Role | What they receive |
|---|---|---|
| PEEP titrations | Other | Not described Receives: Other: PEEP titrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEPCTAC
PEPCTAC (unit : cmH2O)
Measured: Day 0
PEPCAC
PEPCAC (unit : cmH2O)
Measured: Day 0
PEPEIT
PEPEIT (unit : cmH2O)
Measured: Day 0
Secondary outcomes (14)
Percentage of collapse at PEPCTAC
Percentage of collapse at PEPCTAC
Measured: Day 0
Percentage of collapse at PEPCAC
Percentage of collapse PEPCAC
Measured: Day 0
Percentage of collapse at PEPEIT
Percentage of collapse at PEPEIT
Measured: Day 0
Compare respiratory mechanics for PEPCTAC and PEPCAC and PEPEIT
Respiratory mechanics at PEPCTAC and PEPCAC ans PEPEIT : peak and plateau pressure, driving pressure, respiratory system compliance, pulmonary and parietal compliance, respiratory system resistance, end-expiratory transpulmonary pressure, stress index at each PEEP level
Measured: Day 0
Compare PEPCTAC and other PEEP adjustment methods reported in the literature
Comparison of the PEPCTAC level to the PEP level according to the maximum recruitment arm of the Express study (PEP level which is accompanied by a Pplat between 28 and 30 cm H2O), Comparison of the PEPCTAC level to the PEP level according to the PEP/FiO2 scales, Comparison of the PEPCTAC level to the minimum PEEP level to obtain a positive end-expiratory transpulmonary pressure
Measured: Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of distension and collapse resulting from PEEP
- Correlation between variation of plateau pressure with CTAC and percentage of distension linked to PEEP
Measured: Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of collapse resulting from PEEP
- Correlation between variation of plateau pressure with CTAC and percentage of collapsus linked to PEEP
Measured: Day 0
Evaluate the effect of CTAC on plateau pressure based on the distribution of ventilation between dependent and non-dependent zones resulting from PEEP
Correlation between variation of plateau pressure with CTAC and percentage of anterior ventilation
Measured: Day 0
Evaluate the effects of CTAC on regional compliance according to the level of PEP
Regional compliances (four areas of interest with antero-posterior distribution) of the respiratory and pulmonary system estimated using EIT, airway pressure and esophageal pressure
Measured: Day 0
Evaluate the effect of recruitability potential on the level of PEPCTAC and PEPEIT
R/I ratio
Measured: Day 0
Evaluate the effect of airway opening pressure on the level of PEPCTAC and PEPEIT
Evaluation of the airway opening pressure by performing a slow flow pressure-volume curve (quasi-static condition) from a PEEP set at zero cm H2O
Measured: Day 0
Evaluate the effects of PEEP on right ventricular function
Right ventricular function assessed by echocardiography: mitral inflow, subaortic VTI, subpulmonary VTI, continuous-wave pulmonary Doppler and assessment of pulmonary regurgitation, continuous Doppler, TAPSE (tricuspid annular plane systolic excursion), tricuspid annular S-wave. Presence of acute cor pulmonale defined by an RV/LV ratio > 0.6 associated with paradoxical septal motion, PAPi (pulmonary artery pulsatility index). Septal and free-wall right ventricular strains.
Measured: Day 0
Evaluate the effect of PEEP on venous congestion
Venous congestion assessed by ultrasound (VExUS score)
Measured: Day 0
Compare the percentages of distension between PEPCTAC and PEPCAC and PEPEIT
Percentages of distension between PEPCTAC and PEPCAC and PEPEIT
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 posted3 Jun 2026
- Study start7 Apr 2025
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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
- Assessment of ideal PEEP using electrical impedance tomography will be performed as part of usual care but recorded for research purposes. The evaluation of PEEP using the thorax compression maneuver method will be carried out. A blood sample (the "blood gases") will be taken at the ideal PEEP determined by electrical impedance tomography and at the ideal PEEP determined by the manual chest compression maneuver. All of these evaluations will not exceed three hours. Then, usual care will be continued and no further interventions will be carried out as part of the research. The patient will remain included in the study for 28 days in order to collect their health status on the 28th day.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07623590
- Sponsor's protocol ID
- TICTAC
- Acronym
- TICTAC
- Status last verified
- May 2026
- First submitted
- 19 Nov 2024
- Last updated
- 3 Jun 2026
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT07623590
- Acronym / sponsor ID
- TICTAC / TICTAC
- Keywords
- EIT, ARDS, PEEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
Patients with acute respiratory distress syndrome are placed on mechanical ventilation, and the adjustment of ventilator parameters is an important step in their care, in particular positive expiratory pressure, applied at the end of breathing.
The goal of this study is to learn if continuous anterior chest compression works as well as electrical impedance tomography for positive expiratory pressure titration.
Researchers will compare the two methods for each patient, in a randomly determined order : continuous anterior chest compression and electrical impedance tomography.
Participants will :
- have a pep titration with both techniques
- be included in the study for 28 days
Detailed description
Personalizing the PEEP level is an important step in ventilator adjustment in ARDS patients.
The investigators have developed a simple, low-cost method to detect overdistension of the lung, consisting of applying manual compression to the anterior aspect of the patient's thorax, and observing whether the ventilator pressure increases or decreases.
The investigators hypothesize that with this simple method it is possible to determine the PEEP level which corresponds to that determined with EIT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessment of ideal PEEP using electrical impedance tomography will be performed as part of usual care but recorded for research purposes. The evaluation of PEEP using the thorax compression maneuver method will be carried out. A blood sample (the "blood gases") will be taken at the ideal PEEP determined by electrical impedance tomography and at the ideal PEEP determined by the manual chest compression maneuver. All of these evaluations will not exceed three hours. Then, usual care will be continued and no further interventions will be carried out as part of the research. The patient will remain included in the study for 28 days in order to collect their health status on the 28th day.
| Arm | Type | Receives |
|---|---|---|
| PEEP titrations | Other | Other: PEEP titrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Moderate to severe ARDS according to the Berlin criteria
- Patient receiving sedation and continuous curarization
- Free and informed consent from the patient or their loved one
Key exclusion criteria (8 listed)
- ECMO
- Pneumothorax
- Chest trauma in the last 3 months
- Uncontrolled shock (noradrenaline > 5 mg/h)
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| PEEP titrationsAssessment of ideal PEEP using electrical impedance tomography will be performed. The evaluation of PEEP using the thorax compression maneuver method will be carried out. A blood sample (the "blood gases") will be taken at the ideal PEEP determined by electrical impedance tomography and at the ideal PEEP determined by the manual chest compression maneuver. | Other | PEEP titrations |
Primary outcome
PEPCTAC
Time frame: Day 0
PEPCTAC (unit : cmH2O)
PEPCAC
Time frame: Day 0
PEPCAC (unit : cmH2O)
PEPEIT
Time frame: Day 0
PEPEIT (unit : cmH2O)
14 secondary outcomes
Percentage of collapse at PEPCTAC
Time frame: Day 0
Percentage of collapse at PEPCAC
Time frame: Day 0
Percentage of collapse at PEPEIT
Time frame: Day 0
Compare respiratory mechanics for PEPCTAC and PEPCAC and PEPEIT
Time frame: Day 0
Compare PEPCTAC and other PEEP adjustment methods reported in the literature
Time frame: Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of distension and collapse resulting from PEEP
Time frame: Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of collapse resulting from PEEP
Time frame: Day 0
Evaluate the effect of CTAC on plateau pressure based on the distribution of ventilation between dependent and non-dependent zones resulting from PEEP
Time frame: Day 0
Evaluate the effects of CTAC on regional compliance according to the level of PEP
Time frame: Day 0
Evaluate the effect of recruitability potential on the level of PEPCTAC and PEPEIT
Time frame: Day 0
Evaluate the effect of airway opening pressure on the level of PEPCTAC and PEPEIT
Time frame: Day 0
Evaluate the effects of PEEP on right ventricular function
Time frame: Day 0
Evaluate the effect of PEEP on venous congestion
Time frame: Day 0
Compare the percentages of distension between PEPCTAC and PEPCAC and PEPEIT
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 3 Jun 2026.
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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.
Fanny Doroszewski, Mrs contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP titrations in people with ARDS (Acute Respiratory Distress Syndrome), run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Emmanuel Vivier, MD (+33(0)478618209, evivier@saintjosephsaintluc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEPCTAC (time frame: Day 0). 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 3 Jun 2026.