Accuracy of the NICCI™ Monitor in Children and Adolescents

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373746
• Other study ID #: STUDY00000959
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of BP Values From the NICCI Device That Were = 5 mm Hg the Values Obtained From the AC	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. We also calculated the percentage of BP values from the NICCI device that were = 5 mm Hg, = 10 mm Hg, and > 10 mm Hg from the values obtained from the AC.	2-8 hours (average length of major surgery)
Secondary	Percentage of BP Values From the NICCI Device That Were = 10 mm Hg the Values Obtained From the AC	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. We also calculated the percentage of BP values from the NICCI device that were = 5 mm Hg, = 10 mm Hg, and > 10 mm Hg from the values obtained from the AC.	2-8 hours (average length of major surgery)
Secondary	Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC	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. We also calculated the percentage of BP values from the NICCI device that were = 5 mm Hg, = 10 mm Hg, and > 10 mm Hg from the values obtained from the AC.	2-8 hours (average length of major surgery)