Pre-hospital Ventilation Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Ventilator modes used
研究概览
简要总结
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
详细描述
This is a prospective, observational study.
ZOLL will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre-hospital setting. This knowledge and experience will subsequently be used to inform development of a mechanism to allow for automatic data collection and transmission from ZOLL ventilators to a central data repository. These data will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons.
Enrollment in this study is expected to take approximately 24 months. No patient outcome data will be collected.Participants are enrolled once data have been downloaded from the ventilator via RescueNet® VentReview software. Participants will not be followed after the assessment of study objectives.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for this study must meet all of the following Inclusion criteria:
- •Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software
- •Data recorded in ventilator data file
排除标准
- 未提供
研究组 & 干预措施
Ventilator patients
Patients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting.
干预措施: 731 Series Ventilator (Device)
结局指标
主要结局
Ventilator modes used
时间窗: Through study completion, an average 1 hour
Characterizing how often ventilator modes are used during mechanical ventilation
Ventilator settings used
时间窗: Through study completion, an average 1 hour
Characterizing how often ventilator settings are changed during mechanical ventilation
Ventilator Alarm type
时间窗: Through study completion, an average 1 hour
Characterize type of alarms triggered during mechanical ventilation
Ventilator Alarm Frequency
时间窗: Through study completion, an average 1 hour
Characterize frequency of alarms triggered during mechanical ventilation
次要结局
未报告次要终点