Status:

NOT_YET_RECRUITING

Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions:

Patients Receiving Invasive Mechanical Ventilation

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Brief Summary The goal of this clinical trial is to compare whether the novel high-performance emergency transport ventilator (TV80) differs from the intelligent transport ventilator (HAMILTON-T1) in...

Eligibility Criteria

Inclusion

  • Aged ≥ 18 years and \< 80 years.
  • Patients receiving invasive mechanical ventilation.
  • Patients requiring intra-hospital transport or inter-hospital transfer.
  • Patients whose legal representatives have provided written informed consent for participation in the trial.

Exclusion

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

Key Trial Info

Start Date :

December 31 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT07198269

Start Date

December 31 2025

End Date

June 30 2027

Last Update

September 30 2025

Active Locations (1)

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1

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China, 310009

Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients | DecenTrialz