NCT02125331

Measurement of NonInvasive Blood Pressure in Neonates Through Adults and Special Populations

Measurement of NonInvasive Blood Pressure With DINAMAP SuperSTAT and Datex-Ohmeda With Intra-arterial Blood Pressure in Neonates Through Adults and Special Populations

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement algorithms on two commercially available multifunction hemodynamic acquisition modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm ("PDM-SUPERSTAT") and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm ("PSM-Datex-Ohmeda"), provide accurate NIBP measurements in accordance with the guidelines provided by the most recent International Organization for Standardization (ISO) 81060-2:2013. Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and this study is being conducted in accordance with the most recent applicable standards. This study will assess neonate, infant, children, pediatric, adolescent, and adult patients as well as adults with chronic atrial fibrillation in a population that requires non-emergent heart catheterization. This is a study conducted to satisfy both standards for two NIBP devices and, as such, does not require a statistical hypothesis.

Detailed description

This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement algorithms on two commercially available multifunction hemodynamic acquisition modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm ("PDM-SUPERSTAT") and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm ("PSM-Datex-Ohmeda"), provide accurate NIBP measurements in accordance with the guidelines provided by the most recent International Organization for Standardization (ISO) 81060-2:2013. Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and this study is being conducted in accordance with the most recent applicable standards. This study will assess neonate, infant, children, pediatric, adolescent, and adult patients as well as adults with chronic atrial fibrillation in a population that requires non-emergent heart catheterization.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
PROCEDURE	Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)	3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2014-04-29
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

4 sites across 2 countries: United States, India

Regulatory

• FDA-regulated device study