Inspired Helium for Ischemic Protection During Knee Replacement Surgery

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

August 31, 2016

Conditions
Ischemia
Interventions
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

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.

Trial Locations (1)

32610

UF Health, Gainesville

All Listed Sponsors
lead

University of Florida

OTHER

NCT02012361 - Inspired Helium for Ischemic Protection During Knee Replacement Surgery | Biotech Hunter | Biotech Hunter