NCT02744599已完成不适用
Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Breath prompting successful rate
研究概览
简要总结
This is a small trial to test feasibility of an idea for a potential device. The investigators tested the feasibility of prompting a volunteer to breathe when their breathing had slowed down during administration of anesthetic drugs.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesia (ASA) Class I and Class II male and female (non-pregnant/non-lactating) volunteers.
- •Normal healthy individual as indicated by medical history and a physical examination.
- •At least 18 years of age and less than 55 years of age.
- •Negative drug screen.
- •Uncomplicated airway anatomy.
- •A Body Mass Index between 18 and
- •Are fully informed of the risks of entering the study and willingly provide written consent to enter the trial.
- •Female subjects of child bearing potential will have a negative urine pregnancy test on the day the study is conducted.
排除标准
- •Known or suspected neurological pathologies.
- •A history of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter the pharmacokinetics or pharmacodynamics of remifentanil and propofol.
- •Known obstructive sleep apnea.
- •Known or suspected hypersensitivity to any compound present in the study.
- •Any potential subject suffering from medical problems that, in the judgment of the investigator, presents unacceptable risk to the volunteer are not eligible for enrollment.
- •Vulnerable subject groups such as prisoners and the mentally disabled that are traditionally excluded from medical research are also excluded.
- •The potential subject has taken any medication within 2 days prior to chosen drug administration, with the exception of oral contraceptives.
- •The potential subject is wearing artificial nails.
- •A positive urine pregnancy test (females only)
- •Female subjects who are currently lactating & breast-feeding.
- •A positive drug-screening test.
- •The subject consumed food or fluids within 8 hours prior to start of each chosen drug administration.
- •Any medications or alcohol within 2 days prior to start of the chosen drug administration, with the exception of oral contraceptives.
研究组 & 干预措施
Device prompting
Experimental
干预措施: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany (Device)
Control
No Intervention
Patients receive standard of care
结局指标
主要结局
Breath prompting successful rate
时间窗: Change in respiratory rate from baseline to the period 10 seconds after the breath prompt
次要结局
未报告次要终点
研究者
Lara Brewer
Research Assistant Professor
University of Utah
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