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

McGill University

Status: Enrolling

Conditions: Apnea of Prematurity

Treatments: Device: Respiratory Acoustic Sensors; Device: Nasal thermistor; Device: Pneumotachometer; Device: Respiratory Inductive Plethysmography

Study type: Observational

Funder types: Other

Identifiers

NCT05196646

2022-7444

Details and patient eligibility

About

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:

1. To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
2. 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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 72+ hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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 the study
• 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.

Trial design

50 participants in 3 patient groups

(1) 10 preterm infants spontaneously breathing in-room air with no respiratory support

Description:

Group 1 will consist of 10 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a pneumotachometer, i.e. the gold standard. Data will be acquired for 10 minutes.

Treatment:

Device: Pneumotachometer

Device: Respiratory Acoustic Sensors

(2) 20 preterm infants spontaneously breathing in-room air with no respiratory support

Description:

Group 2 will consist of 20 preterm infants spontaneously breathing in room air, with no respiratory support, in whom respiratory acoustic signals from the acoustic sensor will be compared with airflow measurements obtained using a nasal temperature sensor. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI) from the bedside monitor. Data will be continuously recorded for 3 hours.

Treatment:

Device: Respiratory Inductive Plethysmography

Device: Nasal thermistor

Device: Respiratory Acoustic Sensors

(3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events

Description:

Group 3 will consist of 10 preterm infants on CPAP with established cardiorespiratory events, in whom respiratory acoustic signals from the acoustic sensor will be continuously measured for 3 hours. In addition, measurements of respiratory efforts will be obtained using the Respiratory Inductance Plethysmography (RIP), an inertial measurement unit (IMU) integrated within the acoustic sensor, and the Transthoracic Impedance (TTI). Data will be continuously recorded for 3 hours.

Treatment:

Device: Respiratory Inductive Plethysmography

Device: Respiratory Acoustic Sensors