ModPG3 Neo-Infant ISO 81060

Blood Pressure Clinical Trial

Official title:

ModPG3 Neonate and Infant AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05976425
• Other study ID #: 60106449
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Baxter Healthcare Corporation
• Contact: Baxter Clinical Trials Disclosure Call Center
• Phone: (224) 948-7359
• Email: Global_CORP_ClinicalTrialsDisclosure[@]baxter.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• ModPG3 Investigational Device
Connex Vital Sign Monitor with ModPG3 Laptop Data Collection Software USB cable Power strip Welch Allyn FlexiPort Disposable Blood Pressure Cuffs
• Invasive Reference Equipment
Surveyor S12/S19 Hill-Rom ICU Medical data collection cable DIR 60119852 Hill-Rom Edwards data collection cable DIR 60119853

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of the ModPG3 blood pressure (BP) readings with ISO Requirements	Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.	Day 1 (up to one hour)