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NOT YET RECRUITING
NCT07907276

Early Switch in Moderate ARDS

Sponsor: University of Thessaly

View on ClinicalTrials.gov

Summary

The optimal timing for transition from controlled to assisted mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) remains uncertain. Excessive spontaneous respiratory effort may promote injurious transpulmonary pressure swings and heterogeneous regional ventilation, whereas unnecessary prolongation of controlled ventilation may increase sedation exposure and diaphragmatic dysfunction. This prospective, single-center physiological interventional study will enroll mechanically ventilated adults with ARDS and a PaO₂/FiO₂ ratio \>100 and ≤200 mmHg, measured during PEEP=5 cmH2O, who are receiving controlled mechanical ventilation. Participants will undergo a protocolized 30-minute transition from controlled to assisted mechanical ventilation after reduction of sedation sufficient to allow spontaneous respiratory activity. Respiratory effort and drive, airway and esophageal pressures, respiratory flow, respiratory mechanics, gas exchange, and regional ventilation measured by electrical impedance tomography will be assessed before and during the transition. Participants will subsequently be followed for 48 hours to determine whether assisted ventilation can be maintained without return to fully controlled mechanical ventilation.

Official title: Early Switch to Assisted Ventilation in Patients With Moderate ARDS: a Physiological Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-10-01

Completion Date

2028-12-01

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

OTHER

Protocolized Transition From Controlled to Assisted Mechanical Ventilation

Participants receiving controlled mechanical ventilation will undergo gradual reduction of sedation to permit spontaneous respiratory activity, followed by a 30-minute transition to assisted mechanical ventilation. PEEP will remain at the pre-transition value and FiO₂ will remain unchanged whenever clinically feasible. Inspiratory assistance will be titrated to maintain tidal volume at approximately 6-8 mL/kg predicted body weight. Physiological measurements will be recorded continuously, and the procedure will be terminated if prespecified intolerance or safety criteria occur.