Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography (TICTAC)
29. mai 2026 oppdatert av: 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
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Emmanuel Vivier, MD
- Telefonnummer: +33(0)478618209
- E-post: evivier@saintjosephsaintluc.fr
Studer Kontakt Backup
- Navn: Fanny Doroszewski, Mrs
- Telefonnummer: +33(0)47861820 +33(0)478618398
- E-post: fdoroszewski@saintjosephsaintluc.fr
Studiesteder
-
-
-
Créteil, Frankrike, 94000
- Rekruttering
- GHU Henri Mondor
-
Ta kontakt med:
- Guillaume Carteaux, Pr
- Telefonnummer: +33149812111
- E-post: guillaume.carteaux@aphp.fr
-
Hovedetterforsker:
- Guillaume Carteaux, Pr
-
Underetterforsker:
- Pascal Labedade, Dr
-
Lyon, Frankrike, 69007
- Rekruttering
- Hôpital Saint Joseph Saint Luc
-
Hovedetterforsker:
- Emmanuel Vivier, Dr
-
Ta kontakt med:
- Emmanuel Vivier, Dr
- Telefonnummer: +33478618209
- E-post: evivier@saintjosephsaintluc.fr
-
Ta kontakt med:
- Fanny Doroszewski
- Telefonnummer: +33478618398
- E-post: fdoroszewski@saintjosephsaintluc.fr
-
Underetterforsker:
- Samuel Tuffet, Dr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: PEEP-titreringer
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
7. april 2025
Primær fullføring (Antatt)
5. mai 2027
Studiet fullført (Antatt)
5. mai 2027
Datoer for studieregistrering
Først innsendt
19. november 2024
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TICTAC
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