A Pilot Study Investigating the Detection of Episodes of Significant Patient-Ventilator Asynchrony in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of asynchrony events per minute and the asynchrony index
研究概览
简要总结
The goal of this study is to determine what percent of severe patient-ventilator asynchrony is detected in mechanically ventilated patients in the adult ICU and to determine delays in detecting those asynchronies by the staff that were correctly identified, and whether asynchrony status recorded during intermittent assessments by respiratory therapists is representative of periods in between such assessments.
详细描述
This is a prospective observational study. All decisions about ventilator settings, mode of ventilation, and sedative doses are determined by the critical care team attending to the patient. Patients will be enrolled within 6 hours after intubation and will be studied continuously until extubation. Patients will be monitored for asynchrony using Syncron-E tablets provided by Autonomous Healthcare. However, clinical staff will be blinded to the results of the tablet, and hence, there will be no change to clinical care.
Asynchrony index (which captures the fraction of breaths with asynchrony) will be calculated every minute by the Syncron-E tablet. The assessment of respiratory therapists at the time of ventilator checks will also be recorded including the following information: i) entering/exiting the room , ii) existence of a severe asynchrony episode based on the respiratory therapist's assessment and its type. Clinical staff will record the start of any severe asynchrony episode that they detect. Data related to the administrations of sedatives and anesthetics as well as major interventions (excluding any PHI) will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients requiring intensive care unit admission
- •Patients requiring invasive mechanical ventilation expected to last more than 24 hours
- •Patients ventilated on PCV, PSV, VCV, or VC+ ventilation modes
排除标准
- •Any patient not meeting inclusion criteria.
- •Any patient receiving muscle relaxant (paralytics) for more than 24 hours.
- •Any patient receiving inverse ratio ventilation.
结局指标
主要结局
Number of asynchrony events per minute and the asynchrony index
时间窗: Up to 4 weeks
The endpoints will be calculated starting from the end of each ventilator check (when the respiratory therapist is leaving the room) and cover the time from that time point until 5-minutes prior to the next ventilator check event. The endpoints will also be separately calculated for the 5-minute period immediately preceding the next ventilator check.
次要结局
- Number of Syncron-E tablet-detected severe asynchrony episodes that went undetected by clinicians and the number of clinician-detected severe asynchrony episodes undetected by Syncron-E tablet(Up to 4 weeks)
- Time difference between when the Syncron-E tablet detects the start of severe asynchrony episodes and when the clinician-detects the start of severe asynchrony episodes(Up to 4 weeks)