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Inspired Helium for Ischemic Protection During Knee Replacement Surgery

Primary Purpose

Ischemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Control Group
Single-Dose Heliox Group
Muscle Biopsy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemia focused on measuring Ischemic preconditioning, Human limb ischemia, Total knee arthroplasty, Supplemental inspired helium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Single-Dose Heliox Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recovery of quadriceps function
Length of time of transition from a walker to a cane.

Full Information

First Posted
December 10, 2013
Last Updated
August 9, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02012361
Brief Title
Inspired Helium for Ischemic Protection During Knee Replacement Surgery
Official Title
Inspired Helium for Ischemic Protection During Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
Ischemic preconditioning, Human limb ischemia, Total knee arthroplasty, Supplemental inspired helium

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single-Dose Heliox Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control Group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single-Dose Heliox Group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Muscle Biopsy
Intervention Description
During the course of the operation a small muscle biopsy will be collected.
Primary Outcome Measure Information:
Title
Expression of serum markers
Description
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.
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
Recovery of quadriceps function
Description
Length of time of transition from a walker to a cane.
Time Frame
Up to one year
Other Pre-specified Outcome Measures:
Title
Post-surgical time course of potassium
Description
Changes in the time course of the peak level of expression of potassium will be analyzed.
Time Frame
up to 5 days
Title
Post-surgical time course of urea (BUN)
Description
Changes in the time course of the peak level of expression of urea (BUN) will be analyzed.
Time Frame
up to 5 days
Title
Post-surgical time course of lactic acid
Description
Changes in the time course of the peak level of expression of lactic acid will be analyzed.
Time Frame
up to 5 days
Title
Post-surgical time course of lactate dehydrogenase
Description
Changes in the time course of the peak level of expression of lactate dehydrogenase will be analyzed..
Time Frame
up to 5 days
Title
Post-surgical time course of aldolase
Description
Changes in the time course of the peak level of expression of aldolase will be analyzed.
Time Frame
up to 5 days
Title
Post-surgical time course of creatinine phosphokinase (CK)
Description
Changes in the time course of the peak level of expression of creatinine phosphokinase (CK) will be analyzed.
Time Frame
up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron R. Smith, M.D., Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Inspired Helium for Ischemic Protection During Knee Replacement Surgery

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