PReVENT--protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized...

Area of Science:

• Critical Care Medicine
• Respiratory Therapy
• Clinical Trials

Background:

• Lung-protective mechanical ventilation using low tidal volumes is standard for Acute Respiratory Distress Syndrome (ARDS).
• Its use in non-ARDS critically ill patients is uncertain, with potential risks like increased sedation, delirium, and patient-ventilator asynchrony.
• Atelectasis is another potential complication of low tidal volume ventilation.

Purpose of the Study:

• To evaluate the efficacy of a low tidal volume ventilation strategy compared to a high tidal volume strategy in invasively ventilated ICU patients without ARDS.
• To determine if low tidal volume ventilation improves clinical outcomes in this patient population.

Main Methods:

• The PReVENT trial is a national multicenter randomized controlled trial conducted in 5 ICUs in The Netherlands.
• Patients without ARDS, requiring ventilation >24 hours, were randomized to low tidal volume (4-6 ml/kg PBW) or high tidal volume (8-10 ml/kg PBW) ventilation.
• Primary endpoint: ventilator-free days alive at day 28. Secondary endpoints included mortality, length of stay, and pulmonary complications.

Main Results:

• The PReVENT trial is the first RCT to recruit sufficient patients to test low tidal volume ventilation in non-ARDS patients.
• It compares low tidal volume (4-6 ml/kg PBW) against high tidal volume (8-10 ml/kg PBW) ventilation.
• The study assesses clinical endpoints including ventilator-free days, mortality, and pulmonary complications.

Conclusions:

• PReVENT is the first RCT to adequately power a comparison of low vs. high tidal volume ventilation in non-ARDS patients.
• The trial aims to determine if low tidal volume ventilation offers clinical benefits in patients without ARDS.
• Results will inform optimal ventilation strategies for critically ill patients without ARDS.