Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Wi… (NCT07679802) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
France56 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.