NIBP Study for Neonate and Pediatric Subject Populations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorGE Healthcare
About this trial
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age requirement: 0 to < 18 years.
For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
Disqualifiers
Have previously participated in this study (no subject may participate more than once).
Subjects with peripheral arterial diseases (causing left/right arm difference).
Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator.
Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
Trial design
Design model
Single group
Treatments tested in this trial
NIBP Measurement
DeviceThe collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm)Active comparator 1 intervention
Group B: Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Time frame
Up to 12 hours from time of study procedure startOther outcomes
1
Safety Outcome
Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov