Blood Pressure
Conditions
Brief summary
Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Interventions
* Connex Vital Sign Monitor with ModPG3 * Laptop * Data Collection Software * USB cable * Power strip * Welch Allyn FlexiPort Disposable Blood Pressure Cuffs
DEVICEInvasive Reference Equipment
* Surveyor S12/S19 * Hill-Rom ICU Medical data collection cable DIR 60119852 * Hill-Rom Edwards data collection cable DIR 60119853
Sponsors
Welch Allyn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion Criteria * Meets the neonatal or infant (less than 3 years of age) subject population. * The neonate and infant subjects will already have an indwelling intra-arterial line. * Subject's legally authorized representative must consent for the subject to participate. * Subject's legally authorized representative must be able to read, write, speak in English and/or Italian. * Subject must have an arm circumference in the range of 3.3-15.0 cm. * Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line * The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff. 2.
Exclusion criteria
* Lack of Informed consent. * Subjects with deformities or abnormalities that may prevent proper application of the device under test. * Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. * Subjects with known heart dysrhythmias or arrhythmias during the measurement period. * Subjects with compromised circulation or peripheral vascular disease. * Subjects who have had surgery or have shunts or implants in the upper extremity being tested. * Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration. * Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference \> 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading. * Subjects with clotting disorders or taking prescribed blood thinners. * Subjects with a severe contact allergy to sensors or cuff material. * Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of NIBP cuff. * Subjects whose arm circumference does not fall within 3.3 and 15.0 cm. * Arterial line is not properly damped. * The subject has an unstable condition in which NIBP cannot be obtained. * Subjects who have radial or brachial arterial lines. * Subjects who require sedation solely for the purpose of this study and/or prolonged sedation from a prior procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements | Day 1 (up to one hour) | Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020. |
Countries
United States
Participant flow
Pre-assignment details
One subject at the US site signed informed consent but failed screening prior to enrollment. Per protocol, enrollment occurs at assignment/start; therefore, Actual Enrollment and Started both equal 7 subjects.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized < 29 days | 0 Participants |
| Age, Customized >= 29 days to < 3 years | 7 Participants |
| Arm Circumference of ≥3.3-15 cm | 7 Participants |
| Region of Enrollment Italy | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
None listed