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Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients With Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia (EARLY-TCAV)

30 juni 2026 uppdaterad av: Central Hospital, Nancy, France

Efficacy and Safety of Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Requiring Invasive Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia

ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.

Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.

The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.

The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

56

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Intensive care unit hospitalisation for ARDS with a PaO₂/FiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation
  • Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea
  • Onset of symptoms ≤ 7 days
  • Invasive ventilation initiated ≤ 24 hours
  • Affiliation to a social security program
  • Patient for whom written consent has been obtained from a trusted person or a family member, or inclusion in a situation of immediate life-threatening emergency

Exclusion Criteria:

  • Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)
  • Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)
  • Pneumothorax, drained or undrained, with a persistent pleural air leak
  • COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home
  • Circulatory support via VV-ECMO or VA-ECMO
  • Presence of a patent foramen ovale
  • Active limitation of therapies
  • Increased intracranial pressure
  • Sickle cell disease
  • Burns > 30%
  • Expected invasive mechanical ventilation for less than 48 hours
  • A person covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
  • Pregnant or breastfeeding women
  • A not emancipated minor
  • Adults subject to legal protective measures (guardianship, conservatorship, judicial protection) or inability to give consent
  • Persons deprived of liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Time-controlled Adaptative Ventilation
Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode.
Övrig: Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode

Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows:

  • high pressure: initially set at the level of the plateau pressure of the volume control mode
  • low pressure: set at 0 cmH2O (mandatory)
  • time high: initially set at 3 seconds
  • time low: set to terminate the expiratory flow at 75% of peak expiratory flow
  • slope: 0
Aktiv komparator: Volume Control
Invasive ventilation with the ventilator set on the Volume control mode.
Övrig: Volume Control

Invasive ventilation with the ventilator set on the Volume control mode as follows:

  • Tidal volume (VT) set at 6 ml/kg of predicted body weight
  • Positive end-expiratory pressure (PEEP) set according to the low PEEP/FiO2 table

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Extravascular Lung Water (EVLW)
Tidsram: 48 hours
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
48 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality
Tidsram: 60 days
Occurrence of death
60 days
Ventilator-free days
Tidsram: day 30
Number of days without invasive or non-invasive ventilation
day 30
Major Adverse Kidney Events (MAKE)
Tidsram: Day 7, Day 30
Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
Day 7, Day 30
Adverse Events
Tidsram: Day 30

Defined as:

  • Worsening hypoxemia (increase in FiO₂ of more than 40%) within the first 30 minutes after randomization
  • Development of a pneumothorax with a persistent air leak
  • Persistent hemodynamic instability
  • Cardiac Index < 2 L/min/m²,
  • Increase in norepinephrine bitartrate dose > 1 µg/kg/min
  • Persistent acute cor pulmonale
  • Presence of a patent foramen ovale during the first 48 hours after randomization
  • Severe Hypoxemia
  • Severe Acidosis and low tidal volume in the TCAV group
  • Implementation of VV-ECMO or VA-ECMO
  • Tidal volumes exceeding 8 mL/kg of ideal body weight
Day 30
Pressure difference
Tidsram: day 1, day 2, day 3, day 4
in cmH20
day 1, day 2, day 3, day 4
Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
Tidsram: 48 hours
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight
48 hours

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Central Hospital, Nancy, France

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 september 2028

Avslutad studie (Beräknad)

30 november 2028

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2024PI147

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