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Accuracy of the NICCI™ Monitor in Children and Adolescents

Sponsor
Joseph D. Tobias (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04373746
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
25.2
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: NICCI
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Accuracy of the NICCI™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings in Children and Adolescents
Actual Study Start Date :
Oct 26, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10-20 kg

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

Device: NICCI
Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
Experimental: 20-40 kg

Patients undergoing major surgery that weigh between 20-40 kg.

Device: NICCI
Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
Experimental: 40-80 kg

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

Device: NICCI
Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.

Outcome Measures

Primary Outcome Measures

  1. Difference in blood pressure [2-8 hours (average length of major surgery)]

    Difference in BP readings from the non-invasive NICCI device with those obtained from an arterial cannula.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nationwide Children's Hospital Columbus Ohio United States 43205

Sponsors and Collaborators

  • Joseph D. Tobias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joseph D. Tobias, Chief, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT04373746
Other Study ID Numbers:
  • STUDY00000959
First Posted:
May 4, 2020
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Dec 8, 2021