Inspired Helium for Ischemic Protection During Knee Replacement Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Expression of serum markers
研究概览
简要总结
The purpose of this study is to determine whether breathing in helium reduces indications of injury to the skeletal muscle seen in blood tests after knee replacement surgery.
The ability to reduce the risk of skeletal muscle injury may help improve patient safety by providing protection to the area of the body having its blood supply interrupted during a particular surgery.
详细描述
During hospitalization, beginning the day after surgery, additional tests will be added to the daily standard of care blood samples. When daily blood samples are not ordered as part of a study participants care after surgery, blood samples only for the study tests, may be done.
Up to 60 study participants will be selected to be in one of two possible groups.
After hospital discharge the study participants physical therapist will be contacted for copies of the notes and reports about the participants progress in physical therapy. This information will be used to evaluate if the different breathing gases have any impact on how quickly people recover after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Scheduled for an elective total knee arthroplasty
- •> 18 years of age
- •Expected to require inhaled oxygen concentrations < 25%
- •Able to provide informed consent
排除标准
- •Expected to require inhaled oxygen concentrations > 25%
- •< 18 years of age
- •Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).
研究组 & 干预措施
Control Group
This group will be treated as any other patient would. Their anesthesia will be conducted as per routine with a target Fraction of inspired oxygen concentration (FiO2) of 0.25. During the course of the operation a small muscle biopsy will be collected.
干预措施: Muscle Biopsy (Procedure)
Control Group
This group will be treated as any other patient would. Their anesthesia will be conducted as per routine with a target Fraction of inspired oxygen concentration (FiO2) of 0.25. During the course of the operation a small muscle biopsy will be collected.
干预措施: Control Group (Procedure)
Single-Dose Heliox Group
This group will be treated with a single dose of inspired 75/25 heliox (75% helium 25% oxygen) breathed continuously for 15 minutes prior to the inflation of the surgical tourniquet. During the course of the operation a small muscle biopsy will be collected.
干预措施: Single-Dose Heliox Group (Procedure)
Single-Dose Heliox Group
This group will be treated with a single dose of inspired 75/25 heliox (75% helium 25% oxygen) breathed continuously for 15 minutes prior to the inflation of the surgical tourniquet. During the course of the operation a small muscle biopsy will be collected.
干预措施: Muscle Biopsy (Procedure)
结局指标
主要结局
Expression of serum markers
时间窗: up to 5 days
Post-operative expression of serum markers of injury to the skeletal muscle after knee arthroplasty. The primary endpoint will be detection of a decrease in the peak increase of CK detectable in the blood. A 15% decrease will be considered clinically significant.
次要结局
- Recovery of quadriceps function(Up to one year)