ARDS (Acute Respiratory Distress Syndrome)EARLY-TCAVNCT07679802
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
A study of ARDS (Acute Respiratory Distress Syndrome), run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU de Nancy
Nancy, 54000
Matthieu KOSZUTSKI, MD, +33 3 3 83 15 30 17, m.koszutski@chru-nancy.fr
About this study
Official 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
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.
Read more
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.
- Being tested
- Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode, Volume Control
- Keywords
- ARDS, APRV, TCAV, Invasive ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation modeOther
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 ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Time-controlled Adaptative Ventilation | Experimental | Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode. Receives: Other: Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode |
| Volume Control | Active comparator | Invasive ventilation with the ventilator set on the Volume control mode. Receives: Other: Volume Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extravascular Lung Water (EVLW)
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
Measured: 48 hours
Secondary outcomes (6)
Mortality
Occurrence of death
Measured: 60 days
Ventilator-free days
Number of days without invasive or non-invasive ventilation
Measured: day 30
Major Adverse Kidney Events (MAKE)
Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
Measured: Day 7, Day 30
Adverse Events
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
Measured: Day 30
Pressure difference
in cmH20
Measured: day 1, day 2, day 3, day 4
Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679802
- Sponsor's protocol ID
- 2024PI147
- Acronym
- EARLY-TCAV
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07679802
- Acronym / sponsor ID
- EARLY-TCAV / 2024PI147
- Keywords
- ARDS, APRV, TCAV, Invasive ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-controlled Adaptative Ventilation | Experimental | Other: Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation modeInvasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode. |
| Volume Control | Active comparator | Other: Volume ControlInvasive ventilation with the ventilator set on the Volume control mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation modeInvasive 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 | Other | Time-controlled Adaptative Ventilation |
| Volume ControlInvasive 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 | Other | Volume Control |
Primary outcome
Extravascular Lung Water (EVLW)
Time frame: 48 hours
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
6 secondary outcomes
Mortality
Time frame: 60 days
Ventilator-free days
Time frame: day 30
Major Adverse Kidney Events (MAKE)
Time frame: Day 7, Day 30
Adverse Events
Time frame: Day 30
Pressure difference
Time frame: day 1, day 2, day 3, day 4
Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of ARDS (Acute Respiratory Distress Syndrome), run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu KOSZUTSKI, MD (+33 3 83 15 30 17, m.koszutski@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extravascular Lung Water (EVLW) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.