Goal Directed Fluid Management Based on Non-invasive Monitoring

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.

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Key information

Conditions

Postoperative Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal-directed Therapy group

Procedure

Fluid administration is based on the respiratory variation in the pulse oximeter waveform

Other names: Goal Directed Fluid Optimization group

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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 21, 2013
Registry last updated: Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed