Goal Directed Fluid Management Based on Non-invasive Monitoring

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01883752

Enrollment

334

Registered

2013-06-21

Start date

2011-07-31

Completion date

2013-10-31

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complication

Keywords

Goal-directed fluid therapy

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.

Interventions

PROCEDUREGoal-directed Therapy group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026