Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography (TICTAC)

May 29, 2026 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Créteil, France, 94000
        • Recruiting
        • GHU Henri Mondor
        • Contact:
        • Principal Investigator:
          • Guillaume Carteaux, Pr
        • Sub-Investigator:
          • Pascal Labedade, Dr
      • Lyon, France, 69007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: PEEP titrations
Other: PEEP titrations
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PEPCTAC
Time Frame: Day 0
PEPCTAC (unit : cmH2O)
Day 0
PEPCAC
Time Frame: Day 0
PEPCAC (unit : cmH2O)
Day 0
PEPEIT
Time Frame: Day 0
PEPEIT (unit : cmH2O)
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of collapse at PEPCTAC
Time Frame: Day 0
Percentage of collapse at PEPCTAC
Day 0
Percentage of collapse at PEPCAC
Time Frame: Day 0
Percentage of collapse PEPCAC
Day 0
Percentage of collapse at PEPEIT
Time Frame: Day 0
Percentage of collapse at PEPEIT
Day 0
Compare respiratory mechanics for PEPCTAC and PEPCAC and PEPEIT
Time Frame: Day 0
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
Day 0
Compare PEPCTAC and other PEEP adjustment methods reported in the literature
Time Frame: Day 0
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
Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of distension and collapse resulting from PEEP
Time Frame: Day 0
• Correlation between variation of plateau pressure with CTAC and percentage of distension linked to PEEP
Day 0
Evaluate the effect of CTAC on plateau pressure based on levels of collapse resulting from PEEP
Time Frame: Day 0
• Correlation between variation of plateau pressure with CTAC and percentage of collapsus linked to PEEP
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
Correlation between variation of plateau pressure with CTAC and percentage of anterior ventilation
Day 0
Evaluate the effects of CTAC on regional compliance according to the level of PEP
Time Frame: Day 0
Regional compliances (four areas of interest with antero-posterior distribution) of the respiratory and pulmonary system estimated using EIT, airway pressure and esophageal pressure
Day 0
Evaluate the effect of recruitability potential on the level of PEPCTAC and PEPEIT
Time Frame: Day 0
R/I ratio
Day 0
Evaluate the effect of airway opening pressure on the level of PEPCTAC and PEPEIT
Time Frame: Day 0
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
Day 0
Evaluate the effects of PEEP on right ventricular function
Time Frame: Day 0
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.
Day 0
Evaluate the effect of PEEP on venous congestion
Time Frame: Day 0
Venous congestion assessed by ultrasound (VExUS score)
Day 0
Compare the percentages of distension between PEPCTAC and PEPCAC and PEPEIT
Time Frame: Day 0
Percentages of distension between PEPCTAC and PEPCAC and PEPEIT
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TICTAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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