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
Qualifiers
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
Treatments tested in this trial
- NIBP Measurement
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov