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Inspired Helium for Ischemic Protection During Knee Replacement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02012361
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Heliox

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.




Primary Outcome Measures :
  1. Expression of serum markers [ Time Frame: 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 :
  1. Recovery of quadriceps function [ Time Frame: Up to one year ]
    Length of time of transition from a walker to a cane.


Other Outcome Measures:
  1. Post-surgical time course of potassium [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of potassium will be analyzed.

  2. Post-surgical time course of urea (BUN) [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of urea (BUN) will be analyzed.

  3. Post-surgical time course of lactic acid [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of lactic acid will be analyzed.

  4. Post-surgical time course of lactate dehydrogenase [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of lactate dehydrogenase will be analyzed..

  5. Post-surgical time course of aldolase [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of aldolase will be analyzed.

  6. Post-surgical time course of creatinine phosphokinase (CK) [ Time Frame: up to 5 days ]
    Changes in the time course of the peak level of expression of creatinine phosphokinase (CK) will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012361


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Cameron R. Smith, M.D., Ph.D. University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02012361    
Other Study ID Numbers: 201400033
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
Ischemic preconditioning
Human limb ischemia
Total knee arthroplasty
Supplemental inspired helium
Additional relevant MeSH terms:
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Respiratory Aspiration
Ischemia
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases