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Fluid Management Based on Pleth Variability Index (PVI) Monitoring During High-risk Surgery

NCT01788293 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-10

No results posted yet for this study

Summary

Oximetry monitoring is common practice in patients undergoing anesthesia. PVI continuous evaluation may be a possibility of agility and ease of obtaining accurate information about the state of cardiovascular responsiveness to volume expansion.

This prospective and randomized study will try to demonstrate that the assessment of PVI is a simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring technologies. Such a simple approach has therefore the potential for widespread application as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery monitoring technologies in many institutions, as well as in many countries.

Conditions

  • Fluid Loss

Interventions

OTHER

Intervention group

Control group will receive per-operative fluid at the discretion of the anesthetist, whereas Intervention group will receive additional hydroxyethylstarch 6% (HES) bolus in order to minimize and maintain PVI below 14 %. This PVI cut-off value was chosen according to previous reports \[Cannesson et al., 2008; Zimmermann et al., 2010\]. During the postoperative period, both groups were managed by intensivists (in the ICU) and clinicians (in the wards) not involved in the intraoperative management or in data collection. These individuals were not informed of patient allocation.

Sponsors & Collaborators

  • Hospital Regional de Presidente Prudente

    lead OTHER

Principal Investigators

  • Edmundo P Souza Neto, PhD, MD · Hospital Regional de Presidente Prudente

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-01-01
Completion
2018-01-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788293 on ClinicalTrials.gov