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September 2, 2026The Egyptian Journal of Critical Care MedicineOpen Access

Safety and performance evaluation of EZVent mechanical ventilator system in hospitalized mechanically ventilated patients: a single-center, open-label, self-controlled clinical trial

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Authors

YNYasser NassarRGRania A. GalhomIRIsraa Abdel Raouf

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Overview

Open-label self-controlled trial demonstrates stable gas exchange and lung mechanics with the EZVent system in ventilated adults, indicating its clinical safety and functional performance.

Key Points

  • To evaluate the safety and performance of the novel EZVent mechanical ventilator system compared to standard intensive care unit ventilators in hospitalized adults with respiratory failure.
  • Conducted a single-center, open-label, non-randomized, self-controlled clinical trial at Al Kasr Al Ainy Hospital in Egypt (2023–2025) enrolling 22 clinically stable, mechanically ventilated adult patients.
  • Evaluated patients acting as their own controls at baseline on a standard ventilator (T0), after 120 minutes on the EZVent system (T2), and 30 minutes following return to the standard ventilator (T3).
  • Assessed primary endpoints including arterial blood gas metrics, lung mechanics, and vital signs across a mean total ventilation duration of 3.33 ± 0.36 hours.
  • Arterial oxygenation (PaO₂) showed minor improvements and arterial carbon dioxide (PaCO₂) rose slightly without clinical significance, while oxygen saturation (SaO₂) remained stable.
  • Blood pH experienced a small, statistically significant decrease while remaining within normal physiological limits, with no statistically significant differences observed in lung mechanics or vital signs.
  • All physiological variables reverted to baseline levels within 30 minutes of returning to standard ventilators, and zero serious adverse events occurred.

Cite This Study

Nassar et al. (2026) studied this question.

synapsesocial.com/papers/6a98131ec562ede874ec7c5fhttps://doi.org/10.1007/s44349-026-00058-0
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Also Consider

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  1. 1Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial2026
  2. 2Protocol for a single-blind, single-centre, parallel-group, non-inferiority randomised controlled trial: comparison of oxygenation stability between different ventilators in mechanically ventilated patients during intrahospital and interhospital transport2026
  3. 3Technology-Enhanced Strategies to Optimize Positive End-Expiratory Pressure in Patients Receiving Invasive Mechanical Ventilation: A Systematic Review and Meta-Analysis2026
  4. 4Effect of Automated Closed-Loop Ventilation vs Protocolized Conventional Ventilation on Ventilator-Free Days in Critically Ill Adults2025 · 9 citations
  5. 5Continuous-flow ventilation with VENTIJET in moderate ARDS: a pilot safety and feasibility study2026