NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial

Hutchinson Technology

Status: Completed

Conditions: Colorectal Surgery

Treatments: Procedure: Restricted intraoperative fluid management

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731978

H0045

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups

Standard

No Intervention group

Description:

Standard intraoperative fluid management

Restricted

Experimental group

Description:

Restricted intraoperative fluid management

Treatment:

Procedure: Restricted intraoperative fluid management