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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02125331
Recruitment Status : Terminated (Data collection requirment complete)
First Posted : April 29, 2014
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Tracking Information
First Submitted Date April 24, 2014
First Posted Date April 29, 2014
Results First Submitted Date April 29, 2020
Results First Posted Date June 11, 2020
Last Update Posted Date June 11, 2020
Actual Study Start Date April 2014
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2020)
Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: April 25, 2014)
Accuracy of NIBP Measurement [ Time Frame: 60 minutes ]
Determining the accuracy of non-invasive blood pressure measurement compared to invasive blood pressure. A detailed analysis will be conducted on the invasive blood pressure to verify accuracy as defined in the following standards: BS EN 1060-4:2004 and ISO 81060-2 Second edition 2013-05-01.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement of NonInvasive Blood Pressure in Neonates Through Adults and Special Populations
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition 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
Other Names:
  • GE Healthcare CARESCAPE B650 Patient Monitor
  • Patient Side Module with Datex-Ohmeda software algorithm (PSM)
  • Patient Data Module with SuperSTAT software algorithm (PDM)
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Procedure: Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 29, 2020)
83
Original Estimated Enrollment
 (submitted: April 25, 2014)
100
Actual Study Completion Date March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02125331
Other Study ID Numbers 123.04-2013-GES-0008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GE Healthcare
Study Sponsor GE Healthcare
Collaborators Not Provided
Investigators
Principal Investigator: David S Marks, MD, MBA Medical College of Wisconsin
PRS Account GE Healthcare
Verification Date May 2020