- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07623590
Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography (TICTAC)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emmanuel Vivier, MD
- Phone Number: +33(0)478618209
- Email: evivier@saintjosephsaintluc.fr
Study Contact Backup
- Name: Fanny Doroszewski, Mrs
- Phone Number: +33(0)47861820 +33(0)478618398
- Email: fdoroszewski@saintjosephsaintluc.fr
Study Locations
-
-
-
Créteil, France, 94000
- Recruiting
- GHU Henri Mondor
-
Contact:
- Guillaume Carteaux, Pr
- Phone Number: +33149812111
- Email: guillaume.carteaux@aphp.fr
-
Principal Investigator:
- Guillaume Carteaux, Pr
-
Sub-Investigator:
- Pascal Labedade, Dr
-
Lyon, France, 69007
- Recruiting
- Hôpital Saint Joseph Saint Luc
-
Principal Investigator:
- Emmanuel Vivier, Dr
-
Contact:
- Emmanuel Vivier, Dr
- Phone Number: +33478618209
- Email: evivier@saintjosephsaintluc.fr
-
Contact:
- Fanny Doroszewski
- Phone Number: +33478618398
- Email: fdoroszewski@saintjosephsaintluc.fr
-
Sub-Investigator:
- Samuel Tuffet, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TICTAC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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