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

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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
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)
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PDM-SuperSTAT PSM-Datex-Ohmeda
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 58 25
Completed 53 25
Not Completed 5 0
Reason Not Completed
Protocol Violation             1             0
technical problem             2             0
screen failure             2             0
Arm/Group Title PDM-SuperSTAT PSM-Datex-Ohmeda Total
Hide Arm/Group Description

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 58 25 83
Hide Baseline Analysis Population Description
Total of subjects enrolled and assigned to PDM-SuperSTAT arm or PSM-Datex-Ohmeda arm.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Subjects >= 3 years Number Analyzed 58 participants 25 participants 83 participants
34
  58.6%
19
  76.0%
53
  63.9%
Subjects < 3 years Number Analyzed 58 participants 25 participants 83 participants
24
  41.4%
6
  24.0%
30
  36.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 25 participants 83 participants
Female
25
  43.1%
13
  52.0%
38
  45.8%
Male
33
  56.9%
12
  48.0%
45
  54.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Subjects with Chronic Atrial Fibrillation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 25 participants 83 participants
2
   3.4%
0
   0.0%
2
   2.4%
1.Primary Outcome
Title Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements
Hide Description 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.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The PDM-SuperSTAT arm was analyzed according to the ISO 81060-2:2013(E) standard. As the PSM-Datex-Ohmeda was prematurely terminated, PASS/FAIL criteria were unable to be determined.
Arm/Group Title PDM-SuperSTAT PSM-Datex-Ohmeda
Hide Arm/Group Description:

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

The result of the analysis of mean blood pressure measurement errors shows the PDM-SuperSTAT arm population groups ≥ 3 years old and < 3 years old passed the acceptance criteria. However, the Chronic AFib subgroup population of ≥ 3- years old did not meet the subject enrollment because of the challenging population; but as a group, the NIBP determinations for the PDM-SuperSTAT arm for both population group of ≥ 3 years old and < 3 years old showed the study conformed to ISO 81060-2:2013(E) standards.

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

For the PSM-Datex-Ohmeda arm population group ≥ 3 years old and < 3 years old that was prematurely terminated as a result of the business decision that the data was no longer needed to satisfy the business requirements, as a whole, did not meet the ISO 81060-2:2013(E) standards; therefore, PASS/FAIL criteria were unable to be determined.

Overall Number of Participants Analyzed 53 25
Measure Type: Count of Participants
Unit of Measure: Participants
40
  75.5%
19
  76.0%
Time Frame The duration over which adverse events were monitored/assessed was 2 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PDM-SuperSTAT PSM-Datex-Ohmeda
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
PDM-SuperSTAT PSM-Datex-Ohmeda
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
PDM-SuperSTAT PSM-Datex-Ohmeda
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PDM-SuperSTAT PSM-Datex-Ohmeda
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/58 (5.17%)      0/25 (0.00%)    
Injury, poisoning and procedural complications     
Cuff irritation   2/58 (3.45%)  2 /25 
Surgical and medical procedures     
Heart Block  [1]  1/58 (1.72%)  1 /25 
Indicates events were collected by systematic assessment
[1]
Complete heart block secondary to catheter placement not study procedure.
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All proposed publications using study data, in full or in part, will be subject to approval by the Sponsor prior to submission. The Investigator and Sponsor agree to act in good faith to consider the interests of each party in publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Affairs Project Manager
Organization: GE Healthcare
Phone: 262-443-7008
EMail: stephanie.karwedsky@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02125331    
Other Study ID Numbers: 123.04-2013-GES-0008
First Submitted: April 24, 2014
First Posted: April 29, 2014
Results First Submitted: April 29, 2020
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020