Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients

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 terms of oxygenation stability when used for transporting mechanically ventilated patients. It will also collect data on the novel ventilator's performance and safety in multiple transport scenarios. The main questions it aims to answer are:

1. Does the novel high-performance emergency transport ventilator (TV80) show non-inferior oxygenation stability (measured by the difference in oxygenation index before and after transport) compared with HAMILTON-T1 in transporting mechanically ventilated patients?
2. What differences exist between the two ventilators in secondary outcomes such as transport preparation time, changes in PaCO2 and pH before and after transport, and variations in tidal volume, FiO2, heart rate, oxygen saturation, and mean arterial pressure?

We will randomly assign eligible mechanically ventilated patients requiring intra-hospital or inter-hospital transport to either TV80 or HAMILTON-T1 group at a 1:1 ratio, and compare the differences in the above outcomes between the two groups.

Participants will:

1. Be screened for eligibility based on inclusion and exclusion criteria, and their legal representatives will sign the informed consent form.
2. Be randomly assigned to use either TV80 or HAMILTON-T1 group during transport.
3. Undergo blood gas analysis 1 hour after airway intervention stabilization (before transport) and within 1 hour after transport completion to calculate the oxygenation index and changes in PaCO2 and pH.
4. Have transport preparation time recorded (from the start of transport preparation, such as suctioning and pipeline organization, to the confirmation of stable vital signs before transport).
5. Have parameters such as tidal volume, FiO2 (recorded by the ventilator) and heart rate, oxygen saturation, mean arterial pressure (monitored by a incorporated module in TV80 or portable monitor along with HAMILTON-T1) recorded during transport to calculate their variations.
6. Be monitored for adverse events during transport; if severe adverse events occur, the trial will be stopped immediately, and appropriate treatment measures will be taken.

Conditions

• Patients Receiving Invasive Mechanical Ventilation

Interventions

DEVICE

Intelligent emergency ventilator for transport

In this study, eligible patients are first evaluated by research staff to confirm that they meet the inclusion criteria. Once eligibility is established, the research team accesses the electronic data capture (EDC) system via a WeChat QR code, where patients are randomly assigned in a 1:1 ratio to either the domestic ventilator group (TV80) or the imported ventilator group (HAMILTON-T1). After randomization, both patient and ventilator preparation procedures are conducted according to a standardized protocol.

DEVICE

high-performance emergency ventilator for transport

In this study, eligible patients are first evaluated by research staff to confirm that they meet the inclusion criteria. Once eligibility is established, the research team accesses the electronic data capture (EDC) system via a WeChat QR code, where patients are randomly assigned in a 1:1 ratio to either the domestic ventilator group (TV80) or the imported ventilator group (HAMILTON-T1). After randomization, both patient and ventilator preparation procedures are conducted according to a standardized protocol.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Shanxiang Xu, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• China

Study Locations