Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

McGill University Health Centre/Research Institute of the McGill University Health Centre20 enrolled

Overview

The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypoxic-Ischemic Encephalopathy Congenital Heart Disease Stroke Hemorrhagic Aneurysm Cerebral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring * undergoing monitoring with the INVOS wired NIRS system. Exclusion Criteria: * Infants with a skin abnormality that would potentially increase the risk of injury, * Patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.

Outcomes

Primary Outcomes

Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS.

Time frame: 6 months

Secondary Outcomes

Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).

Time frame: 6 months

Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800).

Time frame: 6 months

Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device.

Provide a a custom study questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device. The questionnaire includes Likert-scale items, multiple-choice questions, and open-ended responses evaluating usability, perceived safety, accuracy, comfort, and acceptability. Responses will be summarized descriptively by questionnaire item.

Time frame: 6 months

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts