Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP

Active, not recruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

December 5, 2022

Primary Completion Date

September 28, 2025

Study Completion Date

December 31, 2025

Conditions
Apnea of Prematurity
Interventions
DEVICE

Respiratory Acoustic Sensors

Wireless sensor that contains a dual microphone and an inertial measurement unit (IMU) will capture the breathing sound and respiratory effect. Two wireless sensors will be used, with one placed on the suprasternal notch and the other placed on the right upper chest of the infant, in order to determine the sensor placement yielding the best respiratory signal. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller (ISP1807, Insight SIP) and stored on the same device for future analysis.

DEVICE

Nasal thermistor

The nasal temperature probe that detects changes in temperature between inhaled and exhaled gases allows for the surrogate measure of airflow. It will be placed in one naris and secured with tape at the upper lip or cheek. The nasal temperature signal will be acquired using the Power Lab analog-digital acquisition system and stored for later analysis.

DEVICE

Respiratory Inductive Plethysmography

Two respiratory bands will be placed circumferentially around the infant's chest (at the level of nipple line) and around the abdomen (just above the level of the umbilicus) in order to measure chest and abdominal wall movements, respectively. These movements will be recorded using Respiratory Inductive Plethysmography (Respitrace QDC®, Viasys® Healthcare, USA). The Respitrace® signals will be acquired using the Power Lab data acquisition system and stored for later analysis.

DEVICE

Pneumotachometer

The pneumotachometer is a pressure-differential based flow sensor that is used to measure respiratory flow. It will be connected to a standard face mask that is gently applied to cover the infant's mouth and nose. The face mask will be similar to the masks used as part of standard of care in the NICU for infants who require continuous positive pressure, with or without ventilation. The flow measurements will be recorded using the Power Lab data acquisition system and stored for later analysis.

Trial Locations (1)

H4A 3J1

McGill University Health Center, Montreal

All Listed Sponsors
collaborator

Northwestern University

OTHER

lead

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

OTHER