Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should we Use a Ventilator?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The % Change in Mean Artery Blood Pressure
研究概览
简要总结
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
详细描述
Following cardiac surgery, patients often require ventilation during transport to the intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC. MD, USA) is utilized, but some patients need mechanical ventilation due to concern for oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation over manual ventilation is determined on a case-by-case basis, mostly based on providers' experiences or surgical request, because currently there is no clear clinical evidence behind that. With this clinical study, the investigators intend to build up clinical evidence by comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms: manual ventilation using AMBU bag arm and mechanical ventilation using a transport ventilator.
Objective
In this study, the investigators plan to compare the effects of transport ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation, ventilation, biventricular function, and hemodynamics. This is a two-arm study.
- To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and mean artery pressure in the AMBU bag and Hamilton transport ventilator groups. The investigators hypothesize that using the Hamilton transport ventilator will show a smaller change in P/F ratio, mean artery blood pressures and biventricular function compared to the AMBU bag group. If true, these findings would support using the Hamilton ventilator for transport in appropriate surgical patients.
- To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5:
Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different resistance and compliance settings of the lung simulator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old (any gender or race)
- •Cardiac surgery
- •Require postoperative mechanical ventilation and care in the ICU.
排除标准
- •Patients' refusal
- •Extubation in OR
- •On mechanical circulatory support
- •Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.)
- •Severe RV dysfunction with preoperative echocardiography
- •Contraindication to TEE and pulmonary artery catheter.
研究组 & 干预措施
Arm 1: AMBU bag manual ventilation during transport to the ICU
Arm 2: Hamilton C1 ventilator during transport to the ICU
干预措施: Hamilton C1 ventilator during transport to the ICU (Device)
结局指标
主要结局
The % Change in Mean Artery Blood Pressure
时间窗: Pre-transport hemodynamic values were averaged from the final three readings (taken at 1-min intervals) before switching to the transport monitor, and post-transport readings were recorded immediately after transfer to the ICU monitor.
The % change in mean artery blood pressure before and after the transport to the ICU. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
次要结局
- The % Changes in PaO2/FiO2 (P/F Ratio)(First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.)
- The % Change in PaCO2(First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.)
- The Visual Scale in Changes in Left Ventricular Function(First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.)
- The Visual Scale in Changes in Right Ventricular Function(First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.)
研究者
Yoshihisa Morita, MD
Associate professor
Thomas Jefferson University