Inspired Helium for Ischemic Protection During Knee Replacement Surgery

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.

Study Overview

• Status: Completed
• Conditions: Ischemia
• Intervention / Treatment: Procedure: Control Group; Procedure: Muscle Biopsy; Procedure: Single-Dose Heliox Group

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Muscle Biopsy; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Cameron R. Smith, M.D., Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Ischemic preconditioning; Human limb ischemia; Supplemental inspired helium
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Ischemia; Respiratory Aspiration
• Other Study ID Numbers: 201400033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO