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

NCT02125331 | Terminated Results FDA Device

• 1 other identifier: 123.04-2013-GES-0008
• Study Type: observational
• Target: 83
• Locations: 2 countries
• Sites: 4

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.

Conditions

Blood Pressure

Keywords

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PDM-SuperSTAT

PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650

Procedure: Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)

PSM-Datex-Ohmeda

PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650

Procedure: Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)

Interventions

Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM) PROCEDURE

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

Also known as: GE Healthcare CARESCAPE B650 Patient Monitor, Patient Side Module with Datex-Ohmeda software algorithm (PSM), Patient Data Module with SuperSTAT software algorithm (PDM)

PDM-SuperSTAT; PSM-Datex-Ohmeda

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include neonates with indwelling femoral, radial, or umbilical arterial monitoring lines and infant, pediatric, adolescent, and adult subjects requiring non-emergent surgery involving aortic catheterization (including chronic atrial fibrillation patients among adults and adolescents).

You may qualify if:

• Subjects will be included that:
• 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;
• 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);
• Are expected to be able to provide blood pressure measurements using both IBP and NIBP;
• 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.

You may not qualify if:

• Subjects will be excluded that:
• Have previously participated in this study (no subject may participate more than once).
• Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease in either upper AND/OR lower limbs;
• Have current, uncontrolled circulatory shock;
• Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper cuff application or functioning;
• For women of child-bearing potential, are currently pregnant, suspected to be pregnant, or are currently lactating;
• 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);
• 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;
• 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).

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (4)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Wheaton Franciscan Healthcare - St. Joseph's

Milwaukee, Wisconsin, 53210, United States

Location

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

NH Narayana Multispecialty Hospital, Unit of Narayana Health Mazumdar Shaw Medical Center

Bangalore, 5600 99, India

Location

Limitations and Caveats

Terminated prematurely due to the challenging recruitment of Atrial Fibrillation Patients- PDM arm and PSM arm was prematurely terminated as a result of the business decision that the data was no longer needed to satisfy the business requirements.

Results Point of Contact

• Title: Clinical Affairs Project Manager
• Organization: GE Healthcare

stephanie.karwedsky@ge.com

262-443-7008

Study Officials

• David S Marks, MD, MBA

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); US (3)