Accuracy of the NICCI™ Monitor in Children and Adolescents

NCT04373746 | Completed Results FDA Device

• 1 other identifier: STUDY00000959
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Difference in Blood Pressure

  The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg.

  2-8 hours (average length of major surgery)

Secondary Outcomes (3)

• Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC

  2-8 hours (average length of major surgery)

• Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC

  2-8 hours (average length of major surgery)

• Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC

  2-8 hours (average length of major surgery)

Study Arms (2)

10-40 kg

EXPERIMENTAL

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

Device: NICCI

40-80 kg

EXPERIMENTAL

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

Device: NICCI

Interventions

NICCI DEVICE

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

10-40 kg; 40-80 kg

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

• Title: Dr. Joseph D. Tobias
• Organization: Nationwide Children's Hospital

joseph.tobias@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 4, 2020
• Study Start: October 26, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)