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Accuracy of the NICCI™ Monitor in Children and Adolescents

J

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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