A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)
研究概览
简要总结
The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device.
详细描述
The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device. The ventilator subject of this study is commonly used in the ICU and investigators aim to evaluate its usefulness in the OR. Investigators believe that the ventilator will ventilate with consistent breath rates, adequate tidal volumes and minimal airway pressures. The providers subjective scoring of ease or difficulty of ventilation with each device will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults between 18-74 years of age,
- •ASA status I-III,
- •presenting for elective surgery requiring general anesthesia at the University of Utah
- •able and will to provide informed consent
排除标准
- •oropharyngeal or facial pathology,
- •risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease),
- •known and/or documented difficulty placing an endotracheal tube in the past,
- •limited neck extension or flexion,
- •restrictive lung disease,
- •personal or familial history of malignant hyperthermia
- •known or predicted severe respiratory disease or compromise.
- •Female subjects must have a negative urine pregnancy screen.
结局指标
主要结局
Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)
时间窗: Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation.
Difference in average respiratory rate between manual ventilation and mechanical noninvasive ventilation averaged per patient, then averaged across all studied patients. Unit: 1/min.
Average of the difference in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)
时间窗: Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation
Difference in average tidal volume per ideal body weight between manual ventilation and mechanical noninvasive ventilation, averaged per patient, then averaged across all studied patients. Unit: mL/kg
In-Patient Average Difference of Standard Deviation in Respiratory Rate between Manual and Mechanical Ventilation (1/min)
时间窗: Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation
Difference in standard deviation of respiratory rate between manual ventilation and mechanical noninvasive ventilation averaged per patient, then averaged across all studied patients. Unit: 1/min.
In-Patient Average Difference of Standard Deviation in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)
时间窗: Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation
Difference in standard deviation of tidal volume per ideal body weight between manual ventilation and mechanical noninvasive ventilation, averaged per patient, then averaged across all studied patients. Unit: mL/kg
次要结局
- Difficulty or ease of ventilation as perceived by anesthesia provider(Assessment will be made within one hour after the surgery has been completed.)
研究者
Kai Kuck
Director of Bioengineering, Dept. of Anesthesiology
University of Utah