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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
82
Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
Nationwide Children's Hospital
Columbus, Ohio, United States
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.
Time frame: 2-8 hours (average length of major surgery)
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.
Time frame: 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.
Time frame: 2-8 hours (average length of major surgery)
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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.
Time frame: 2-8 hours (average length of major surgery)