Inspired Helium for Ischemic Protection During Knee Replacement Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Inspired Helium for Ischemic Protection During Knee Replacement Surgery

Conditions
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Ischemia

Intervention / Treatment
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* Procedure: Control Group
* Procedure: Single-Dose Heliox Group
* Procedure: Muscle Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for an elective total knee arthroplasty > 18 years of age Expected to require inhaled oxygen concentrations < 25% Able to provide informed consent Exclusion Criteria: Expected to require inhaled oxygen concentrations > 25% < 18 years of age Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Procedure: Control Group<br>* 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.<br>Procedure: Muscle Biopsy<br>* During the course of the operation a small muscle biopsy will be collected.<br>|
| Active Comparator: Single-Dose Heliox Group<br>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. | Procedure: Single-Dose Heliox Group<br>* 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.<br>Procedure: Muscle Biopsy<br>* During the course of the operation a small muscle biopsy will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of quadriceps function | Length of time of transition from a walker to a cane. | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic preconditioning, Human limb ischemia, Total knee arthroplasty, Supplemental inspired helium