Inspired Helium for Ischemic Protection During Knee Replacement Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2016 |
| Start Date: | October 2014 |
| End Date: | October 2017 |
| Contact: | Judith M. Wishin, BSN |
| Email: | jwishin@anest.ufl.edu |
| Phone: | 352-273-9096 |
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.
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.
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.
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.
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.).
We found this trial at
1
site
Gainesville, Florida 32608
Principal Investigator: Cameron R. Smith, M.D., Ph.D.
Phone: 352-494-3165
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