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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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. |
|
| Single-Dose Heliox Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Procedure | This group will be treated as any other patient would. Their anesthesia will be conducted as per routine with a target FiO2 of 0.25, (25%oxygen / 75%nitrogen) the only exception being that they will not be treated with inspired heliox. |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of serum markers | 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. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of quadriceps function | Length of time of transition from a walker to a cane. | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical time course of potassium | Changes in the time course of the peak level of expression of potassium will be analyzed. | up to 5 days |
| Post-surgical time course of urea (BUN) | Changes in the time course of the peak level of expression of urea (BUN) will be analyzed. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cameron R. Smith, M.D., Ph.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Single-Dose Heliox Group | Procedure | This group will be treated with a single dose of inspired 75/25 heliox (75% helium 25% oxygen) breathed continuously for 15 minutes over any convenient window prior to the inflation of the surgical tourniquet. This will be the only change in their clinical care. Their anesthesia will be conducted as per routine and as the anesthesia team sees fit with a target FiO2 of 0.25, the only exception being that they will receive 75/25 heliox prior to the inflation of the tourniquet. |
|
| Muscle Biopsy | Procedure | During the course of the operation a small muscle biopsy will be collected. |
|
| up to 5 days |
| Post-surgical time course of lactic acid | Changes in the time course of the peak level of expression of lactic acid will be analyzed. | up to 5 days |
| Post-surgical time course of lactate dehydrogenase | Changes in the time course of the peak level of expression of lactate dehydrogenase will be analyzed.. | up to 5 days |
| Post-surgical time course of aldolase | Changes in the time course of the peak level of expression of aldolase will be analyzed. | up to 5 days |
| Post-surgical time course of creatinine phosphokinase (CK) | Changes in the time course of the peak level of expression of creatinine phosphokinase (CK) will be analyzed. | up to 5 days |
| D008722 | Methods |