Evaluation of Non-Invasive Hemoglobin in Trauma Patients | NCT03123328

NCT03123328

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
Test Subjects	Experimental	Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.	Device: Radical-7 Pulse CO-Oximeter and sensor

Name	Type	Description	Arm Group Labels	Other Names
Radical-7 Pulse CO-Oximeter and sensor	Device	Noninvasive device that measures hemoglobin.	Test Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SpHb's Ability to Detect Critical Drops	The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.	Up to 24 hours.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Test Subjects	Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU. Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Test Subjects	Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU. Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin.

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

SpHb's Ability to Detect Critical Drops

The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.

Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 50 subjects with at least 2 blood samples to conduct an interim analysis to calculate final sample size in order to obtain to a definition of critical drop detection. This study was not able to meet this target and therefore a critical drop could not be defined (primary outcome measure).

Posted

Up to 24 hours.

ID	Title	Description
OG000	Test Subjects	Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU. Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin.

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	Test Subjects	Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU. Radical-7 Pulse CO-Oximeter and sensor: Noninvasive device that measures hemoglobin.