MightySat - Clinical Performance Comparison Study | NCT03239574

NCT03239574

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
MightySat Test group	Experimental	The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.	Device: MightySat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MightySat	Device	MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study	MightySat Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of RRp Determination	Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.	approximately 30-40 minutes

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Masimo Clinical Lab		Irvine	California	92618	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	MightySat Test Group	The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter. MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	MightySat Test Group	The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter. MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study

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, Categorical			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

Accuracy of RRp Determination

Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Posted

Number

breaths per minute

approximately 30-40 minutes

ID	Title	Description
OG000	MightySat Test Group	The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter. MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study

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	MightySat Test Group	The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter. MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study