Patients Receiving Invasive Mechanical VentilationNCT07198269
Assessment of A Novel Emergency Transport Ventilator in Mechanically Ventilated Patients
A study testing Intelligent emergency ventilator for transport and high-performance emergency ventilator for transport in people with Patients Receiving Invasive Mechanical Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Receiving Invasive Mechanical Ventilation
- What is being tested?
- Intelligent emergency ventilator for transport and high-performance emergency ventilator for transport
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
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
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:
Read more
- 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?
- 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:
- Be screened for eligibility based on inclusion and exclusion criteria, and their legal representatives will sign the informed consent form.
- Be randomly assigned to use either TV80 or HAMILTON-T1 group during transport.
- 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.
- 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).
- 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.
- 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.
- Being tested
- Intelligent emergency ventilator for transport, high-performance emergency ventilator for transport
- Keywords
- Transport ventilators, Oxygenation stability, Randomized controlled trial, Mechanical ventilation, Non-inferiority
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent emergency ventilator for transportDevice
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.
high-performance emergency ventilator for transportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Novel high-performance ventilator for transport | Experimental | Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80 Receives: Device: Intelligent emergency ventilator for transport; Device: high-performance emergency ventilator for transport |
| Intelligent ventilator for transport | Active comparator | Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1 Receives: Device: Intelligent emergency ventilator for transport; Device: high-performance emergency ventilator for transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 hour before and 1 hour after transport
Secondary outcomes (8)
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
Measured: Procedure (From the beginning to the end of transport)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Procedure (The interval from preparing the patient's ventilator and monitor tubing/lines to transferring the patient onto the stretcher)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients Receiving Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanxiang Xu, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198269
- Sponsor's protocol ID
- 2025-0931
- Other IDs
- 2022YFC2403604
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32467466Hernandez-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.
PubMed 37709164Jiang 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.
PubMed 42129997
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07198269
- Acronym / sponsor ID
- 2025-0931
- Keywords
- Transport ventilators, Oxygenation stability, Randomized controlled trial, Mechanical ventilation, Non-inferiority
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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:
- Be screened for eligibility based on inclusion and exclusion criteria, and their legal representatives will sign the informed consent form.
- Be randomly assigned to use either TV80 or HAMILTON-T1 group during transport.
- 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.
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel high-performance ventilator for transport | Experimental | Device: Intelligent emergency ventilator for transport, Device: high-performance emergency ventilator for transportMechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80 |
| Intelligent ventilator for transport | Active comparator | Device: Intelligent emergency ventilator for transport, Device: high-performance emergency ventilator for transportMechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent emergency ventilator for transportIn 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 | Intelligent ventilator for transport, Novel high-performance ventilator for transport |
| high-performance emergency ventilator for transportIn 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 | Intelligent ventilator for transport, Novel high-performance ventilator for transport |
Primary outcome
Difference in PaO2/FiO2 before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
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.
8 secondary outcomes
Variation in heart rate before and after transferring
Time frame: Procedure (From the beginning to the end of transport)
Variation in SPO2 before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
Variation inPaCO2 before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
Variation in tidal volume before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
Difference in pH before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
Variation in FiO2 before and after transferring
Time frame: Within 1 hour before and 1 hour after transport
Variation in mean arterial pressure and after transferring
Time frame: From the beginning to the end of transport
Preparing time for transferring
Time frame: Procedure (The interval from preparing the patient's ventilator and monitor tubing/lines to transferring the patient onto the stretcher)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Results publication: PubMed 32467466Cardinale 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.
- Results publication: PubMed 37709164Hernandez-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.
- Derived from this study: PubMed 42129997Jiang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanxiang Xu, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent emergency ventilator for transport and high-performance emergency ventilator for transport in people with Patients Receiving Invasive Mechanical Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanxiang Xu, PhD (+86 13757119126, 2201027@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in PaO2/FiO2 before and after transferring (time frame: Within 1 hour before and 1 hour after transport). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198269, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.