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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

NCT07679802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-07-01

No results posted yet for this study

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)

Interventions

OTHER

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

OTHER

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

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-09-30
Completion
2028-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679802 on ClinicalTrials.gov