Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit | NCT07732244

NCT07732244

Overview

NCT ID: NCT07732244
Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
Official Title: Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study
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.).
Conditions: Hypoxic-Ischemic Encephalopathy
Congenital Heart Disease

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Central Contacts: Alyssa Maximov, BScContact
alyssa.maximov@muhc.mcgill.ca5149341934 ext. 78229