Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Wireless NIRS

    Device

    Wireless NIRS applied to participant forehead.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Wireless Near-infrared spectroscopy (NIRS)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
6 months

Secondary outcomes

1

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 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
2

Comparison of derived Heart Rate Variability (HRV) 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).

Time frame
6 months
3

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

Other outcomes

Sponsors and contacts

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