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

Comparing PVI Measurements at Different Sensing Locations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02124551

Enrollment

Registered

2014-04-28

Start date

2014-04-30

Completion date

2017-07-31

Last updated

2021-03-29

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

Conditions

Fluid Imbalance

Keywords

Goal-directed fluid therapy

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PVI measurement of fluid responsiveness	Intra-operative	The primary outcome is to test the ability of PVI recorded at the finger and at the ear to predict fluid responsiveness.

Countries

United States

Outcome results