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The Impact of High-Performance Emergency Transport Ventilators on Oxygenation Stability in Mechanically Ventilated Patients: A Single-Center, Parallel-Group, Non-Inferiority Randomized Controlled Trial

The Impact of High-Performance Emergency Transport Ventilators on Oxygenation Stability in Mechanically Ventilated Patients: A Single-Center, Parallel-Group, Non-Inferiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110266
Enrollment
Unknown
Registered
2025-10-11
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory failure

Interventions

control group (HAMILTON-T1):Imported emergency transport ventilator
Intervention group (TV80):domestically produced high-performance emergency transport ventilator

Sponsors

Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years and < 80 years. (2) Patients receiving invasive mechanical ventilation. (3) Patients requiring intra-hospital transport or inter-hospital transfer. (4) Patients whose legal representatives have provided written informed consent for participation in the trial.

Exclusion criteria

Exclusion criteria: (1) Subjects with shock or hemodynamic instability that has not been treated (2) Subjects receiving high-dose vasopressor support (equivalent norepinephrine dose > 1µg/kg/min) (3) Patients receiving ECMO support (4) Subjects with hemoglobin < 6g/dL (5) Subjects with cardiac arrest without resuscitation treatment (6) Patients who are moribund or discharged due to deteriorating condition (7) Patients with bullae, pneumothorax without closed thoracic drainage, especially tension pneumothorax (8) Massive hemoptysis, and respiratory failure caused by massive hemoptysis or severe aspiration (9) Pregnant and lactating women (10) Patients with mental illness (11) Subjects whose legal representatives have not provided informed consent (12) Patients without access to trial ventilators during the trial, including when trial ventilators are in use or malfunctioning (13) Expected transport duration exceeding 1 hour or combined transport scenarios (helicopter combined with ambulance)

Design outcomes

Primary

MeasureTime frame
Difference in PaO2/FiO2 before and after transferring;

Secondary

MeasureTime frame
Variation in heart rate before and after transferring;Variation in SPO2 before and after transferring;Variation inPaCO2 before and after transferring;Variation in tidal volume before and after transferring;Preparing time for transferring;Difference in pH before and after transferring;Variation in mean arterial pressure and after transferring;Variation in FiO2 before and after transferring;

Countries

China

Contacts

Public ContactShanxiang Xu

Second Affiliated Hospital, Zhejiang University School of Medicine

2201027@zju.edu.cn+86 137 5711 9126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026