Aneurysm Cerebral, Congenital Heart Disease, Hypoxic-Ischemic Encephalopathy, Stroke Hemorrhagic
Conditions
Keywords
NIRS, Near-Infrared Spectroscopy, Wireless Sensor, Technology, NICU
Brief summary
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.).
Interventions
DEVICEWireless NIRS
Wireless NIRS applied to participant forehead.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. | 6 months | Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). | 6 months | Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). |
| Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). | 6 months | Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). |
| Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device. | 6 months | 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. |
Countries
Canada
Contacts
CONTACTAlyssa Maximov, BSc
PRINCIPAL_INVESTIGATORGuilherme Sant'Anna, MD, PhD
RI-MUHC
Outcome results
None listed