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

29. maj 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Créteil, Frankrig, 94000
        • Rekruttering
        • GHU Henri Mondor
        • Kontakt:
        • Ledende efterforsker:
          • Guillaume Carteaux, Pr
        • Underforsker:
          • Pascal Labedade, Dr
      • Lyon, Frankrig, 69007

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: PEEP titreringer
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PEPCTAC
Tidsramme: Day 0
PEPCTAC (unit : cmH2O)
Day 0
PEPCAC
Tidsramme: Day 0
PEPCAC (unit : cmH2O)
Day 0
PEPEIT
Tidsramme: Day 0
PEPEIT (unit : cmH2O)
Day 0

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of collapse at PEPCTAC
Tidsramme: Day 0
Percentage of collapse at PEPCTAC
Day 0
Percentage of collapse at PEPCAC
Tidsramme: Day 0
Percentage of collapse PEPCAC
Day 0
Percentage of collapse at PEPEIT
Tidsramme: Day 0
Percentage of collapse at PEPEIT
Day 0
Compare respiratory mechanics for PEPCTAC and PEPCAC and PEPEIT
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 0
R/I ratio
Day 0
Evaluate the effect of airway opening pressure on the level of PEPCTAC and PEPEIT
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 0
Venous congestion assessed by ultrasound (VExUS score)
Day 0
Compare the percentages of distension between PEPCTAC and PEPCAC and PEPEIT
Tidsramme: Day 0
Percentages of distension between PEPCTAC and PEPCAC and PEPEIT
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. april 2025

Primær færdiggørelse (Anslået)

5. maj 2027

Studieafslutning (Anslået)

5. maj 2027

Datoer for studieregistrering

Først indsendt

19. november 2024

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TICTAC

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Kliniske forsøg med ARDS (Acute Respiratory Distress Syndrome)

Kliniske forsøg med PEEP titrations

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