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

Phase

N/A

Condition

N/A

Treatment

Respiratory Inductive Plethysmography

Pneumotachometer

Nasal thermistor

Clinical Study ID

NCT05196646

2022-7444

Ages > 72
All Genders

Study Summary

This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.

The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants.

The study's secondary objectives are:

To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.

Eligibility Criteria

Inclusion

Inclusion Criteria for all infants:

Gestational age < 32+0 weeks
Postmenstrual age between 28+0 and 36+6 weeks.

Additional inclusion criteria for Groups 1 and 2:

Off any respiratory support and breathing in-room air
Less than 3 clinically significant cardiorespiratory events per calendar day

Additional inclusion criteria for Group 3:

On the bubble CPAP device with the binasal prongs interface
Receiving CPAP levels of 5 to 7 cm H2O with gas flows not exceeding 10L/min
At least 3 clinically significant cardiorespiratory events per calendar day

Exclusion

Exclusion Criteria:

Major known congenital abnormalities
Known congenital heart disorders
Known neuromuscular disease
Known diaphragmatic paralysis or a diagnosed phrenic nerve injury
History of esophageal perforation in the 7 days preceding the study
History of pneumothorax requiring chest tube insertion in the 7 days preceding thestudy
Receiving inotropes, narcotics, or sedative agents at the time of study recording

Additional exclusions at the time of the study recording:

Infants receiving ventilator-derived CPAP
Infants receiving CPAP via a nasal mask interface.
Infants receiving inotropes, narcotics or sedative agents
Infants deemed clinically unstable for the study by the attending neonatologist.

Study Design

Respiratory Inductive Plethysmography

December 05, 2022

March 31, 2025

Study Description

Cardiorespiratory events, defined by the occurrence of apneas, bradycardias, and desaturations, are almost ubiquitous in very preterm infants and are associated with numerous complications. Unfortunately, the current standard for monitoring cardiorespiratory events in the NICU, transthoracic impedance (TTI), does not permit for accurate differentiation of the different types of cardiorespiratory events; TTI cannot detect airflow and has low accuracy for detecting respiratory efforts. As a result, TTI does not detect obstructive apneas and may not reliably capture all central apneas.

Respiratory sounds are an attractive surrogate measure of airflow, and can be captured using respiratory acoustic technology (akin to a miniaturized electronic stethoscope). We hypothesize that respiratory acoustic monitoring can provide a continuous, non-invasive, and accurate representation of airflow and breathing sounds in preterm infants.

Altogether, we conjecture that the combination of respiratory acoustic monitoring with measurements of respiratory effort will improve the ability to differentiate and describe the nature of cardiorespiratory events in preterm infants.

Connect with a study center

McGill University Health Center
Montreal, Quebec H4A 3J1
Canada
Active - Recruiting

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