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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Difference in PaO2/FiO2 before and after transferring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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)
研究组 & 干预措施
Novel high-performance ventilator for transport
Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80
干预措施: high-performance emergency ventilator for transport (Device)
Intelligent ventilator for transport
Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1
干预措施: Intelligent emergency ventilator for transport (Device)
Intelligent ventilator for transport
Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving HAMILTON-T1
干预措施: high-performance emergency ventilator for transport (Device)
Novel high-performance ventilator for transport
Mechanically ventilated patients who requiring intra-hospital or inter-hospital transport with various objects will receiving TV80
干预措施: Intelligent emergency ventilator for transport (Device)
结局指标
主要结局
Difference in PaO2/FiO2 before and after transferring
时间窗: 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.
次要结局
- Variation inPaCO2 before and after transferring(Within 1 hour before and 1 hour after transport)
- Variation in heart rate before and after transferring(Procedure (From the beginning to the end of transport))
- Variation in SPO2 before and after transferring(Within 1 hour before and 1 hour after transport)
- Variation in tidal volume before and after transferring(Within 1 hour before and 1 hour after transport)
- Difference in pH before and after transferring(Within 1 hour before and 1 hour after transport)
- Variation in FiO2 before and after transferring(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)
- Preparing time for transferring(Procedure (The interval from preparing the patient's ventilator and monitor tubing/lines to transferring the patient onto the stretcher))