Accuracy of the NICCI™ Monitor in Children and Adolescents

Not Applicable

Completed

Conditions: Anesthesia
Surgery

Interventions: Device: NICCI

Registration Number: NCT04373746

Lead Sponsor: Joseph D. Tobias

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10-40 kg	NICCI	Patients undergoing major surgery that weigh between 10-20 kg.
40-80 kg	NICCI	Patients undergoing major surgery that weigh between 40-80 kg.

Primary Outcome Measures

Name	Time	Method
Difference in Blood Pressure	2-8 hours (average length of major surgery)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.