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

NCT07679802 | Not Yet Recruiting

• 1 other identifier: 2024PI147
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS; APRV; TCAV; Invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Extravascular Lung Water (EVLW)

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

  48 hours

Secondary Outcomes (6)

• Mortality

  60 days

• Ventilator-free days

  day 30

• Major Adverse Kidney Events (MAKE)

  Day 7, Day 30

• Adverse Events

  Day 30

• Pressure difference

  day 1, day 2, day 3, day 4

Study Arms (2)

Time-controlled Adaptative Ventilation

EXPERIMENTAL

Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode.

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.

Other: Volume Control

Interventions

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

Time-controlled Adaptative Ventilation

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

Volume Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Matthieu KOSZUTSKI, MD

CONTACT

+33 3 83 15 30 17; m.koszutski@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)