N/A
N=82
Accuracy of the NICCI™ Monitor in Children and Adolescents
Surgery · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04373746 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Difference in Blood Pressure — 11; 10; 10; 9 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NICCI (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Joseph D. Tobias
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Blood Pressure |
11; 10; 10; 9; 10; 9 | — |
| SECONDARY Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC |
32; 35; 35; 39; 31; 31 | — |
| SECONDARY Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC |
57; 60; 60; 67; 56; 56 | — |
| SECONDARY Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC |
43; 40; 40; 33; 44; 44 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04373746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.