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Completed

NCT Number: NCT02124551

Comparing Pleth Variability Index (PVI) Measurements at Different Sensing Locations

The purpose of this study is to assess the suitability of the ear and forehead as a better site for measure of fluid responsiveness.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

The aim of this study is to compare Pleth Variability Index (PVI) measurements at different sensor locations in respect to signal quality, sensor fit to site location and fluid responsiveness. PVI will be measured at 3 different sensor sites: the fingers, ear lobes and forehead. The ability to predict fluid responsiveness will be analyzed using cardiac output as the reference value.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Undergo any type of surgeries under general anesthesia in UCI Medical Center
  • Mechanically ventilated during surgery
  • Arterial line placement is preferred but not required
  • Agree to sign the consent and HIPAA forms

Exclusion criteria

  • Less than 18 years of age
  • Pregnant women
  • Refused to sign the consent and HIPAA forms
  • Receive vasoactive medication prior to surgery
  • Has these conditions: hypotension, hypothyroidism, moderate or poorly controlled hypertension, chronic poorly-controlled diabetes, heart failure patients, and patients with active airway flow obstruction, left ventricular dysfunction, intra-cardiac shunts, right ventricular dysfunction, atrial fibrillation, arrhythmias
  • patients with surgeries at or around site of sensor placement
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study

Treatment and study plan

Primary outcomes

  1. PVI measurement of fluid responsiveness

    Time frame: Intra-operative

    The primary outcome is to test the ability of PVI recorded at the finger and at the ear to predict fluid responsiveness.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Masimo Corporation

Registry information

Official study title

Comparing PVI Measurements at Different Sensing Locations

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2014
Registry last updated
Mar 29, 2021

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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