Accuracy of the NICCI™ Monitor in Children and Adolescents

NCT ID: NCT04373746

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2021-12-30

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.

Conditions

Surgery; Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

10-40 kg

Patients undergoing major surgery that weigh between 10-20 kg.

Group Type: EXPERIMENTAL

NICCI

Intervention Type: DEVICE

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

40-80 kg

Patients undergoing major surgery that weigh between 40-80 kg.

Group Type: EXPERIMENTAL

NICCI

Intervention Type: DEVICE

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

Interventions

NICCI

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

Intervention Type: DEVICE

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph D. Tobias

OTHER

Sponsor Role: lead

Responsible Party

Joseph D. Tobias

Chief, Dept. of Anesthesiology & Pain Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00000959

Identifier Type: -

Identifier Source: org_study_id