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

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements	60 minutes	Comparison of the following measurements: non-invasive blood pressure to invasive blood pressure. This is done with a beat to beat comparison. Each pulse from the analyzed time interval (non-invasive blood pressure determination) provides a systolic, MAP and diastolic value and that is compared to the waveform collected at the same timepoint for the invasive BP (measurement). Criteria is defined in ANSI/AAMI/ISO 81060-2 NIBP Standard. Mean \& SD of the IBP derived from the IBP wave recordings during a NIBP determination will be calculated; and the range of reference IBP will be determined as mean ±1 standard deviation (SD) of the IBPs. The same method will be used for both systolic and diastolic blood pressures. Data may be excluded for analysis when the range of invasive systolic BP is wider than 20 mmHg or when the range of invasive diastolic BP is wider than 12 mmHg, as such that analysis is performed in accordance with ISO 81060-2:2013.

Secondary Outcome Measures

Name	Time	Method

Locations (4): NH Narayana Multispecialty Hospital, Unit of Narayana Health Mazumdar Shaw Medical Center
🇮🇳
Bangalore, India
Wheaton Franciscan Healthcare - St. Joseph's
🇺🇸
Milwaukee, Wisconsin, United States
Froedtert Hospital/Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States