Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT07198269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Comparison of Oxygenation Stability Between Different Ventilators in Mechanically Ventilated Patients During Transport: a Single-blind, Single-center, Parallel-group, Non-inferiority Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022YFC2403604 | OTHER_GRANT | National Key Research and Development Program of China | View |