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

NCT05196646 | Active Not Recruiting

• 1 other identifier: 2022-7444
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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:

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

Conditions

Apnea of Prematurity

Keywords

Airflow; Apnea; Cardiorespiratory events; Monitoring; Neonatal Intensive Care; Preterm infants; Respiratory acoustics; Prematurity; CPAP; Acoustic monitoring

Outcome Measures

Primary Outcomes (1)

• Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.

  The airflow signal derived from the respiratory acoustic sensor will be compared with the airflow signal derived from the pneumotachometer.

  10 minutes (group 1) or 3 hours (groups 2 and 3)

Secondary Outcomes (2)

• Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Respiratory Inductance Plethysmography (RIP).

  3 hours (groups 2 and 3 only)

• Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Transthoracic Impedance (TTI).

  3 hours (groups 2 and 3 only)

Study Arms (3)

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

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.

Device: Respiratory Acoustic Sensors; Device: Pneumotachometer

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

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.

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

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

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.

Device: Respiratory Acoustic Sensors; Device: Respiratory Inductive Plethysmography

Interventions

Respiratory Acoustic Sensors DEVICE

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.

(1) 10 preterm infants spontaneously breathing in-room air with no respiratory support; (2) 20 preterm infants spontaneously breathing in-room air with no respiratory support; (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events

Nasal thermistor DEVICE

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.

Also known as: MLT415/A®, ADInstruments®, Bella Vista, Australia

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

Respiratory Inductive Plethysmography DEVICE

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.

Also known as: SleepSense®, Scientific Laboratory Products, Elgin, USA

(2) 20 preterm infants spontaneously breathing in-room air with no respiratory support; (3) 20 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events

Pneumotachometer DEVICE

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.

Also known as: Hans Rudolph, Inc, Shawnee, KS

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

Eligibility Criteria

• Age: 72 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.

You may qualify if:

• Gestational age \< 32+0 weeks
• Postmenstrual age between 28+0 and 36+6 weeks.
• Off any respiratory support and breathing in-room air
• Less than 3 clinically significant cardiorespiratory events per calendar day
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Northwestern University: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wissam M Shalish, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 19, 2022
• Study Start: December 5, 2022
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)