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Completed

NCT Number: NCT04373746

Accuracy of the NICCI™ Monitor in Children and Adolescents

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.

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Key information

Conditions

Surgery Anesthesia

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NICCI

Device

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

Primary outcomes

  1. Difference in Blood Pressure

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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