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

Blood Pressure Clinical Trial

— MISSION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02125331
• Other study ID #: 123.04-2013-GES-0008
• Status: Terminated
• Start date: April 2014
• Est. completion date: March 2019

Study information

• Verified date: May 2020
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

INCLUSION CRITERIA

Subjects will be included that:

1. Are aged >29 days requiring clinically indicated non-emergent heart catheterization OR aged =29 days with placed or scheduled placement of an indwelling femoral, radial, or umbilical arterial monitoring line;

2. Have an upper limb (right OR left side) that fits a cuff size of the device (circumference ranging 3 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm);

3. Are expected to be able to provide blood pressure measurements using both IBP and NIBP;

4. Are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent with assent from minor patients, as required by IRB policy.

EXCLUSION CRITERIA

Subjects will be excluded that:

1. Have previously participated in this study (no subject may participate more than once).

2. Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease in either upper AND/OR lower limbs;

3. Have current, uncontrolled circulatory shock;

4. Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper cuff application or functioning;

5. For women of child-bearing potential, are currently pregnant, suspected to be pregnant, or are currently lactating;

6. Have any condition that could interfere with the subjects ability to tolerate the procedure, including having a maximum of 4 fast flushes (adult, adolescent, or pediatric patients aged >29 days) or 1 fast flush (neonates aged <29 days);

7. If aged greater than 29 days but less than 12 years of age, have previously had any clinical or research procedure requiring general anesthesia in the last 3 month period;

8. If aged greater than 29 days but less than 12 years of age, are expected to require more than three (3) total hours of continuous general anesthesia for the scheduled procedure (including clinically necessary anesthesia and anticipated 25 minute extension for study purposes).

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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

Locations

Country	Name	City	State
India	NH Narayana Multispecialty Hospital, Unit of Narayana Health Mazumdar Shaw Medical Center	Bangalore
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Froedtert Hospital/Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare - St. Joseph's	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements	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.	60 minutes