NCT04373746

Accuracy of the NICCI™ Monitor in Children and Adolescents

Accuracy of the NICCI™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings in Children and Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Joseph D. Tobias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study that will compare the blood pressure readings from an arterial cannula with those obtained non-invasively by the NICCI device. The study will enroll 50 patients into each of three weight ranges: 10-20 kg, 20-40 kg, and 40-80 kg. The NICCI, Pulsion/GETINGE uses novel technology to provide a continuous estimation of BP displayed as a waveform similar to that seen with an invasive arterial cannula, but is totally non-invasive by using the fingers. The patient rests their hand on the device, which is about the size of a computer mouse, and then a blood pressure cuff goes around their upper arm.

Conditions

• Surgery
• Anesthesia

Interventions

Type	Name	Description
DEVICE	NICCI	Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-05-04
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study