Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Respiratory Distressed assessed by Respiratory Distress Observation Scale (RDOS)
研究概览
简要总结
The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This device will detect the amount of carbon dioxide exhaled with each breath and may better predict high levels of this than traditional monitoring. This may reduce the number and severity of respiratory issues. A convenience sample of 60 participants either scheduled for continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.
详细描述
The purpose of this proposal is to explore the relationships between End Tidal Carbon Dioxide (ETCO2) via nasal cannula (ETCO2-NC) and routinely measured physiologic and participant reported parameters in extubated participants who have received a continuous flow left ventricular assist device (CF-LVAD), and to determine if the addition of ETCO2-NC monitoring to usual care is associated with decreased incidence and severity of respiratory issues.
A convenience sample of 60 participants either scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.
Investigators seek to examine the relationship between ETCO2-NC with traditional physiologic measures, clinical assessments, and participant reported symptoms in persons with a CF-LVAD. Additionally, this study intends to compare the respiratory outcomes of extubated persons with a CF-LVAD randomized to usual care to those receiving usual care plus ETCO2- NC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Scheduled for mechanical circulatory support device (MCSD) implant or have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD)
- •New York Heart Association (NYHA) functional class III to IV
- •Ability to read, write, and speak English
排除标准
- •Requiring mechanical ventilation during the active phase of the trial
研究组 & 干预措施
Standard Respiration Monitoring
Participants scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD) will receive standard respiratory monitoring throughout their stay in the ICU.
干预措施: Standard Non-invasive Respiratory Depression Monitoring (Other)
Standard Respiration Monitoring + Continuous ETCO2-NC
Participants scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD) will receive standard respiratory monitoring and continuous end-tidal capnography monitoring via nasal cannula (ETCO2-NC) throughout their stay in the ICU.
干预措施: Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC) (Device)
Standard Respiration Monitoring + Continuous ETCO2-NC
Participants scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD) will receive standard respiratory monitoring and continuous end-tidal capnography monitoring via nasal cannula (ETCO2-NC) throughout their stay in the ICU.
干预措施: Standard Non-invasive Respiratory Depression Monitoring (Other)
结局指标
主要结局
Respiratory Distressed assessed by Respiratory Distress Observation Scale (RDOS)
时间窗: Up to 2 Weeks
The RDOS is an ordinal level scale with eight observer-rated parameters: heart rate, respiratory rate, accessory muscle use, paradoxical breathing pattern, restlessness, grunting at end-expiration, nasal flaring, and a fearful facial display. Each parameter is scored from 0 to 2 points and the points are summed. Scale scores range from 0 signifying no distress to 16 signifying the most severe distress.
Dyspnea Rate assessed by the Dyspnea Visual Analogue Scale (DVAS)
时间窗: Up to 2 Weeks
The DVAS is a self-reported scale that asks participants to indicate how much shortness of breath they are experiencing by marking on a line 100 mm in length between "no shortness of breath" and "shortness of breath as bad as can be".
Severity of Respiratory Depression
时间窗: Up to 2 Weeks
Physiologic data abstracted from the medical record: Severity of respiration depression will be collected via standard hospital code met and code blue forms. Respiratory compromise will be defined as respiratory rate increase or decrease by 20% or greater, an ETCO2 value greater than 20% above baseline values, or a SpO2 less than 90% for greater than 10 seconds.
Incidence of Respiratory Depression
时间窗: Up to 2 Weeks
This is physiologic data abstracted from the medical record: respiration that has a rate below 12 breaths per minute or that fails to provide full ventilation and perfusion of the lungs.
次要结局
未报告次要终点
研究者
Carolyn Miller Reilly
Assistant Professor
Emory University