Pleth Variability Index (PVI) to Predict Fluid Responsiveness

NCT03120910 | Withdrawn FDA Device

• 1 other identifier: FLEM0005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Clinical utility of PVI

  Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness.

  1-5 hours

Study Arms (1)

Test Subjects

EXPERIMENTAL

All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensor, including nasal sensors, with the same or similar technology and materials as the Masimo FDA cleared devices and sensors.

Device: Pulse CO-Oximeter Sensor

Interventions

Pulse CO-Oximeter Sensor DEVICE

Investigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc.

Test Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
• Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure

You may not qualify if:

• Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study
• Patients with cardiac arrhythmias
• Patients with intracardiac shunts

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: December 15, 2016
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)