Inspired Helium for Ischemic Protection During Knee Replacement Surgery

University of Florida

Status and phase: Completed; Phase 1

Conditions: Ischemia

Treatments: Procedure: Single-Dose Heliox Group; Procedure: Muscle Biopsy; Procedure: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02012361

201400033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control Group

Active Comparator group

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.

Treatment:

Procedure: Muscle Biopsy

Procedure: Control Group

Single-Dose Heliox Group

Active Comparator group

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.

Treatment:

Procedure: Muscle Biopsy

Procedure: Single-Dose Heliox Group