NCT07198269

Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients

Not yet recruiting NA Last updated 30 September 2025

What this trial tests

NA trial testing Intelligent emergency ventilator for transport in Patients Receiving Invasive Mechanical Ventilation in 98 participants. Not yet recruiting.

Timeline

31 December 2025

Primary endpoint
31 December 2026

30 June 2027

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	31 December 2025
Primary completion	31 December 2026
Estimated completion	30 June 2027
Sites	1 location across China

Drugs / interventions tested

• Intelligent emergency ventilator for transport
• high-performance emergency ventilator for transport

Conditions studied

• Patients Receiving Invasive Mechanical Ventilation — all drugs for Patients Receiving Invasive Mechanical Ventilation →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 80, any sex, with Patients Receiving Invasive Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Jiang S, Yang M, Wang H, Guo X, et al · · 2026 · PMID 42129997 · DOI 10.1136/bmjopen-2025-111661