NCT02012361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

December 10, 2013

Last Update Submit

August 9, 2019

Conditions

Ischemia

Keywords

Ischemic preconditioningHuman limb ischemiaTotal knee arthroplastySupplemental inspired helium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Recovery of quadriceps function

    Up to one year

Other Outcomes (6)

  • Post-surgical time course of potassium

    up to 5 days

  • Post-surgical time course of urea (BUN)

    up to 5 days

  • Post-surgical time course of lactic acid

    up to 5 days

  • +3 more other outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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 GroupProcedure: Muscle Biopsy

Single-Dose Heliox Group

ACTIVE COMPARATOR

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 GroupProcedure: Muscle Biopsy

Interventions

Control GroupPROCEDURE

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.

Control Group
Single-Dose Heliox GroupPROCEDURE

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.

Single-Dose Heliox Group
Muscle BiopsyPROCEDURE

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

Control GroupSingle-Dose Heliox Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for an elective total knee arthroplasty
  • \> 18 years of age
  • Expected to require inhaled oxygen concentrations \< 25%
  • Able to provide informed consent

You may not qualify if:

  • Expected to require inhaled oxygen concentrations \> 25%
  • \< 18 years of age
  • Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Ischemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Cameron R. Smith, M.D., Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 16, 2013

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

August 1, 2016

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)