Clinical trial NCT05196646: Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
Official title: Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Apnea of Prematurity
Keywords: Airflow
Apnea
Cardiorespiratory events
Monitoring
Neonatal Intensive Care
Preterm infants
Respiratory acoustics
Prematurity
CPAP
Acoustic monitoring
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2022-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.

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. 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
timeFrame: 10 minutes (group 1) or 3 hours (groups 2 and 3)
Secondary outcomes:
measure: Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Respiratory Inductance Plethysmography (RIP).
timeFrame: 3 hours (groups 2 and 3 only)
measure: Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Transthoracic Impedance (TTI).
timeFrame: 3 hours (groups 2 and 3 only)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Wissam M Shalish, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: