NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial
Not Applicable
Completed
- Conditions
- Colorectal Surgery
- Interventions
- Procedure: Restricted intraoperative fluid management
- Registration Number
- NCT00731978
- Lead Sponsor
- Hutchinson Technology Inc
- Brief Summary
The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery.
The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Scheduled for elective open colorectal surgery
- Age greater than or equal to 18 years
- Low to moderate risk colorectal surgery patients
Exclusion Criteria
- Unacceptable Baseline vital sign measurements
- High risk colorectal surgery patients
- Jehovah's Witness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restricted Restricted intraoperative fluid management Restricted intraoperative fluid management
- Primary Outcome Measures
Name Time Method Major postoperative complications within the first 30 days of the postoperative period
- Secondary Outcome Measures
Name Time Method StO2 changes during intraoperative fluid management, hospital-free days, surgical site infections, time to first bowel movement, total fluid and total intraoperative fluid volumes, daily fluid volumes through 3 days postoperative, daily weights within the first 30 days of the postoperative period
Trial Locations
- Locations (2)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of Texas Health Science Center (UTHSCSA)
🇺🇸San Antonio, Texas, United States