Validation of RPVi as a Parameter to Predict Fluid Respon... | NCT03706430

NCT03706430

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulse Co-Oximeter sensor	Experimental	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.	Device: Pulse CO-Oximeter sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse CO-Oximeter sensor	Device	Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of RPVi to SVV and/or PPV	To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.	approximately 2-6 hours during surgery

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Los Angeles		Los Angeles	California	90095	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Pulse Co-Oximeter Sensor	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. Pulse CO-Oximeter sensor: Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00063 subjects
COMPLETED		FG00048 subjects
NOT COMPLETED		FG00015 subjects

Type	Comment	Reasons
No A-Line placed		FG0005 subjects
Subject had gel nail polish		FG0001 subjects
Nail length causing difficulties with sensor		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Pulse Co-Oximeter Sensor	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. Pulse CO-Oximeter sensor: Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Comparison of RPVi to SVV and/or PPV

To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.

Zero subjects were collected for validation as the study was terminated in the data collection phase due to slow enrollment

Posted

approximately 2-6 hours during surgery

ID	Title	Description
OG000	Pulse Co-Oximeter Sensor	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. Pulse CO-Oximeter sensor: Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pulse Co-Oximeter Sensor	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. Pulse CO-Oximeter sensor: Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.