Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022YFC2403604 | Other Grant/Funding Number | National Key Research and Development Program of China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel high-performance ventilator for transport | Experimental | Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80 |
|
| Intelligent ventilator for transport | Active Comparator | Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent emergency ventilator for transport | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PaO2/FiO2 before and after transferring | Arterial blood samples will be collected within 1 hour before and 1 hour after transport. Blood gas analysis will be performed to obtain PaO2 and FiO2 values and calculate the oxygenation index. The difference between the two indices is then determined. | Within 1 hour before and 1 hour after transport |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in heart rate before and after transferring | From the beginning to the end of transport, obtain data recorded manually or from the ventilator to determine the minimum and maximum heart rates during the entire process, and calculate the difference between them | Procedure (From the beginning to the end of transport) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanxiang Xu, PhD | Contact | +86 13757119126 | 2201027@zju.edu.cn | |
| Shouyin Jiang, PhD | Contact | 15988854485 | jansoean@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shanxiang Xu, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32467466 | Result | Cardinale M, Cungi PJ, Bordes J, Cohergne F, Schmitt S, Langlois A, Meaudre E, Lacroix G. Maintaining a high inspired oxygen fraction with the Elisee 350 turbine transport ventilator connected to two portable oxygen concentrators in an austere environment. J Trauma Acute Care Surg. 2020 Sep;89(3):e59-e63. doi: 10.1097/TA.0000000000002792. | |
| 37709164 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| high-performance emergency ventilator for transport | Device | 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. |
|
| Variation in SPO2 before and after transferring |
From the beginning to the end of transport, retrieve data recorded manually or from the ventilator to identify the minimum and maximum oxygen saturation levels throughout the process, and calculate the difference between them |
| Within 1 hour before and 1 hour after transport |
| Variation inPaCO2 before and after transferring | Arterial blood samples are collected within 1 hour before and 1 hour after transport. Blood gas analysis is performed to obtain PaCO₂ values before and after transport, and the difference between them is calculated | Within 1 hour before and 1 hour after transport |
| Variation in tidal volume before and after transferring | From the beginning to the end of transport, retrieve data from the ventilator to identify the minimum and maximum delivered tidal volumes throughout the process, and calculate the difference between them | Within 1 hour before and 1 hour after transport |
| Difference in pH before and after transferring | Arterial blood samples are collected within 1 hour before and 1 hour after transport. Blood gas analysis is performed to obtain pH values before and after transport, and the difference between them is calculated. | Within 1 hour before and 1 hour after transport |
| Variation in FiO2 before and after transferring | From the beginning to the end of transport, retrieve data from the ventilator to identify the minimum and maximum delivered FiO₂ values throughout the process, and calculate the difference between them | Within 1 hour before and 1 hour after transport |
| Variation in mean arterial pressure and after transferring | From the beginning to the end of transport, retrieve data recorded manually or from the ventilator to identify the minimum and maximum mean arterial pressures throughout the process, and calculate the difference between them | From the beginning to the end of transport |
| Preparing time for transferring | The time interval from preparing the patient's ventilator and monitor tubing and lines to transferring the patient onto the stretcher | Procedure (The interval from preparing the patient's ventilator and monitor tubing/lines to transferring the patient onto the stretcher) |
| Hernandez-Tejedor A, Gonzalez Puebla V, Corral Torres E, Benito Sanchez A, Pinilla Lopez R, Galan Calategui MD. Ventilatory improvement with mechanical ventilator versus bag in non-traumatic out-of-hospital cardiac arrest: SYMEVECA study, phase 1. Resuscitation. 2023 Nov;192:109965. doi: 10.1016/j.resuscitation.2023.109965. Epub 2023 Sep 12. |
| 42129997 | Derived | Jiang S, Yang M, Wang H, Guo X, Wei J, Qi W, Li K, Xu S. 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. BMJ Open. 2026 May 12;16(5):e111661. doi: 10.1136/bmjopen-2025-111661. |