Inspired Helium for Ischemic Protection During Knee Replacement Surgery
NCT ID: NCT02012361
Last Updated: 2019-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-10-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
Muscle Biopsy
During the course of the operation a small muscle biopsy will be collected.
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.
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.
Muscle Biopsy
During the course of the operation a small muscle biopsy will be collected.
Interventions
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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.
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.
Muscle Biopsy
During the course of the operation a small muscle biopsy will be collected.
Eligibility Criteria
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Inclusion Criteria
* \> 18 years of age
* Expected to require inhaled oxygen concentrations \< 25%
* Able to provide informed consent
Exclusion Criteria
* \< 18 years of age
* Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).
18 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Cameron R. Smith, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health
Gainesville, Florida, United States
Countries
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Other Identifiers
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201400033
Identifier Type: -
Identifier Source: org_study_id
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