Protocol 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 transport.

Abstract

Mechanical ventilation during patient transport is a high-risk clinical practice. While the novel Mindray TV80, a high-performance emergency transport ventilator, offers potential advantages for use across complex transport settings, rigorous clinical data comparing its oxygenation performance in critically ill, mechanically ventilated patients during transport are lacking. This study aims to address this gap by evaluating the non-inferiority of TV80 to Hamilton T1 in maintaining oxygenation stability. This is a prospective, single-blind, single-centre, parallel-group, non-inferiority randomised controlled trial. Mechanically ventilated patients (18-80 years) requiring intrahospital or interhospital transport will be recruited. Eligible patients will be randomised at a 1:1 ratio to the TV80 group (intervention) or Hamilton T1 group (control) using a permuted block design stratified by transport type (intrahospital vs interhospital) via the electronic data capture system. The intervention involves using the assigned ventilator during transport, with parameters replicated from the patient's pre-transport ventilator. The primary outcome is the difference in oxygenation index (P/F) before (within 1 hour) and after (within 1 hour) transport as measured by blood gas analyser. Continuous SpO₂ monitoring will be performed throughout the transport period to capture real-time oxygenation changes. Secondary outcomes include transport preparation time, changes in PaCO₂ and pH, variability of ventilator parameters (tidal volume, FiO₂) and vital signs (heart rate, SpO₂, mean arterial pressure) and incidence of adverse events (AEs)/serious AEs. Sample size is 98 (49 per group) to achieve 80% power with a non-inferiority margin of -30 mm Hg. Pre-specified subgroup analyses by transport type will be performed. This study has been approved by the Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine (approval number: LSY-2025-0903). Written informed consent will be obtained from participants' legal representatives. All results will be submitted to a peer-reviewed journal for publication. NCT07198269 (ClinicalTrials.gov).