NCT01883752CompletedNot Applicable

Goal-Directed Fluid Management Based on Non- Invasive Monitoring of Pulse Oximeter-Derived Pleth Variability Index

University of California, Irvine1 site in 1 country334 target enrollmentStarted: July 1, 2011Last updated: February 10, 2016

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of California, Irvine
Enrollment: 334
Locations: 1
Primary Endpoint: Duration of hospital stay

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

Control

No Intervention

Baseline crystalloid infusion of 5 mL/kg/hr of body weight.

Goal-directed Therapy group

Experimental

Goal-direct therapy

Intervention: Goal-directed Therapy group (Procedure)

Outcomes

Primary Outcomes

Duration of hospital stay

Time Frame: Maximum 90 days after surgery

The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

University of California, Irvine

Sponsor Class

Other

Responsible Party

Principal Investigator

Maxime Cannesson

Associate Professor

University of California, Irvine

Study Sites (1)

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