Blood Pressure
Conditions
Keywords
Blood Pressure
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.
Interventions
PROCEDUREDevice: 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
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 58 |
| 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
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 | 25 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | screen failure | 2 | 0 |
| Overall Study | technical problem | 2 | 0 |
Baseline characteristics
| Characteristic | PDM-SuperSTAT | PSM-Datex-Ohmeda | Total |
|---|---|---|---|
| Age, Customized Subjects < 3 years | 24 Participants | 6 Participants | 30 Participants |
| Age, Customized Subjects >= 3 years | 34 Participants | 19 Participants | 53 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 13 Participants | 38 Participants |
| Sex: Female, Male Male | 33 Participants | 12 Participants | 45 Participants |
| Subjects with Chronic Atrial Fibrillation | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 25 |
| other Total, other adverse events | 3 / 58 | 0 / 25 |
| serious Total, serious adverse events | 0 / 58 | 0 / 25 |
Outcome results
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.
Time frame: 60 minutes
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PDM-SuperSTAT | Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements | 40 Participants |
| PSM-Datex-Ohmeda | Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements | 19 Participants |