Accuracy of the NICCI™ Monitor in Children and Adolescents

Joseph D. Tobias

Status: Completed

Conditions: Surgery; Anesthesia

Treatments: Device: NICCI

Study type: Interventional

Funder types: Other

Identifiers

NCT04373746

STUDY00000959

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring anesthetic care and in whom an indwelling arterial cannula will be placed for the surgical procedure.

Exclusion criteria

• Patients with history of a peripheral neurologic or neuropathic disorder
• Patients in whom the upper extremity cannot be used for blood pressure monitoring
• Patients in whom an invasive arterial cannula cannot be placed
• Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
• Edematous patients

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

10-40 kg

Experimental group

Description:

Patients undergoing major surgery that weigh between 10-20 kg.

Treatment:

Device: NICCI

40-80 kg

Experimental group

Description:

Patients undergoing major surgery that weigh between 40-80 kg.

Treatment:

Device: NICCI