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NCT Number: NCT07679802

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

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.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode

Other

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

Volume Control

Other

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

Primary outcomes

  1. Extravascular Lung Water (EVLW)

    Time frame: 48 hours

    Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight

Secondary outcomes

  1. Mortality

    Time frame: 60 days

    Occurrence of death

  2. Ventilator-free days

    Time frame: day 30

    Number of days without invasive or non-invasive ventilation

  3. Major Adverse Kidney Events (MAKE)

    Time frame: Day 7, Day 30

    Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death

  4. Adverse Events

    Time frame: 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

  5. Pressure difference

    Time frame: day 1, day 2, day 3, day 4

    in cmH20

  6. Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)

    Time frame: 48 hours

    Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight

Study contacts

Contact information is provided by the study sponsor or research team.

Matthieu KOSZUTSKI, MD

CONTACT

[email protected]

+33 3 83 15 30 17

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: EARLY-TCAV

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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