Accuracy of the NICCI™ Monitor in Children and Adolescents

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgery, Anesthesia

Intervention / Treatment
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* Device: NICCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10-40 kg<br>Patients undergoing major surgery that weigh between 10-20 kg. | Device: NICCI<br>* Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.<br>|
| Experimental: 40-80 kg<br>Patients undergoing major surgery that weigh between 40-80 kg. | Device: NICCI<br>* Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |