Goal Directed Fluid Management Based on Non-invasive Monitoring

Not Applicable

Completed

• Conditions: Postoperative Complication
• Interventions: Procedure: Goal-directed Therapy group

• Registration Number: NCT01883752
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.

Detailed Description

The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery.

In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of surgery.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

• Patients (male or female)
• Over 18 years old undergoing non-cardiac surgery
• Weight > 40 kg, Body Mass Index < 40

Exclusion Criteria

• Patients who do not consent
• Body Mass Index > 40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-directed Therapy group	Goal-directed Therapy group	Goal-direct therapy

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	Maximum 90 days after surgery	The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States