Inspired Helium for Ischemic Protection During Knee Replacement Surgery

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02012361

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemia	Procedure: Control Group Procedure: Single-Dose Heliox Group Procedure: Muscle Biopsy	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Inspired Helium for Ischemic Protection During Knee Replacement Surgery

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Control Group 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. Procedure: Muscle Biopsy During the course of the operation a small muscle biopsy will be collected.
Active Comparator: 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.	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 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. Procedure: Muscle Biopsy During the course of the operation a small muscle biopsy will be collected.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Control Group

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.

Procedure: Muscle Biopsy

During the course of the operation a small muscle biopsy will be collected.

Active Comparator: 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.

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 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.

Procedure: Muscle Biopsy

During the course of the operation a small muscle biopsy will be collected.

Outcome Measures

Primary Outcome Measures

Expression of serum markers [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.

Secondary Outcome Measures

Recovery of quadriceps function [Up to one year]
Length of time of transition from a walker to a cane.

Other Outcome Measures

Post-surgical time course of potassium [up to 5 days]
Changes in the time course of the peak level of expression of potassium will be analyzed.
Post-surgical time course of urea (BUN) [up to 5 days]
Changes in the time course of the peak level of expression of urea (BUN) will be analyzed.
Post-surgical time course of lactic acid [up to 5 days]
Changes in the time course of the peak level of expression of lactic acid will be analyzed.
Post-surgical time course of lactate dehydrogenase [up to 5 days]
Changes in the time course of the peak level of expression of lactate dehydrogenase will be analyzed..
Post-surgical time course of aldolase [up to 5 days]
Changes in the time course of the peak level of expression of aldolase will be analyzed.
Post-surgical time course of creatinine phosphokinase (CK) [up to 5 days]
Changes in the time course of the peak level of expression of creatinine phosphokinase (CK) will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.).