跳至主要内容
临床试验/CTRI/2019/06/019488
CTRI/2019/06/019488招募中不适用

Correlation of Swan-Ganz catheter readings and/or TransesophagealEchocardiogram (TEE) with Barocardiogram (BCG) in PerioperativePatients

Respirix Inc1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
Respirix Inc
入组人数
100
试验地点
1
主要终点
To identify, and, if possible, validate any observed relationships between BCG and TEE and/or Swan-Ganz catheter

研究概览

简要总结

The Cardiospire device is a non-invasive home-use device that has the ability to detect minor, cyclic waveforms caused by cardiac pulses, or cardiogenic oscillations (COS) in the bulk pressure and flow measurements of expiration. The COS waveform is caused by blood, after being ejected from the right ventricle, pulsing through the pulmonary vasculature, which cyclically expands/contracts against the lung tissue and causes a flow/pressure pulsation in air within the airway. Accordingly, features of the COS waveform provide information about cardiac and pulmonary function. Measurements of these COS waveforms from the patient airway have significant potential to diagnose disorders of the cardiovascular and respiratory systems; we refer to these COS recordings as barocardiogram (BCG).

In a previous study we monitored BCG in post-operative cardiac surgery patients by monitoring pressure in the endotracheal tube during a short pause in ventilation and demonstrated that the BCG is both (1) highly repeatable and (2) responsive to pre-load dependent patients.

In this study, we aim to evaluate and quantify the relationships between BCG and parameters determined using Swan-Ganz catheters and/or TEE in cardiac surgery patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient must ≥ 18 years of age 2.Scheduled for either: Cardiac valve replacement and/or repair (surgical or transcatheter) AND/OR Coronary artery bypass grafting (CABG) 3.Patient will receive Swan Ganz Catheter and/or intraoperative Transesophageal Echocardiogram
  • Able to provide informed consent.

排除标准

  • Subjects who, at the principal investigator’s determination, would not tolerate a 10 second ventilator pause.
  • Subjects who, at the principal investigator’s determination, would not be appropriate for this study.

结局指标

主要结局

To identify, and, if possible, validate any observed relationships between BCG and TEE and/or Swan-Ganz catheter

时间窗: 1. One measurement before the chest is opened | 2. One measurement with open chest | 3.One measurement before closure of chest | 4. One measurement after chest closure

measurements.

时间窗: 1. One measurement before the chest is opened | 2. One measurement with open chest | 3.One measurement before closure of chest | 4. One measurement after chest closure

次要结局

未报告次要终点

研究者

发起方
Respirix Inc
申办方类型
Other [Company ]

研究点 (1)

Loading locations...

相似试验