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Goal Directed Fluid Management Based on Non-invasive Monitoring

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Postoperative Complication

Treatments

Procedure: Goal-directed Therapy group

Study type

Interventional

Funder types

Other

Identifiers

NCT01883752
UCIANES01

Details and patient eligibility

About

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.

Full 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.

Enrollment

334 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

334 participants in 2 patient groups

Control
No Intervention group
Description:
Baseline crystalloid infusion of 5 mL/kg/hr of body weight.
Goal-directed Therapy group
Experimental group
Description:
Goal-direct therapy
Treatment:
Procedure: Goal-directed Therapy group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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