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

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ClinicalTrials.gov Identifier: NCT05196646
Recruitment Status : Not yet recruiting
First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Collaborators:
Université de Sherbrooke
Université de Montréal
Information provided by (Responsible Party):
Wissam Shalish, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

This is an observational, proof-of-concept, feasibility study where 25 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 respiratory acoustic monitoring at detecting breathing sounds in preterm infants.

The study's secondary objective is to compare transthoracic impedance, respiratory inductive plethysmography and electrical activity of the diaphragm for the detection of respiratory efforts in preterm infants.


Condition or disease Intervention/treatment
Apnea of Prematurity Device: Respiratory Acoustic Sensor Device: Electrical Activity of the diaphragm catheter

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.

Moreover, the electrical activity of the diaphragm (EAdi) represents a promising alternative surrogate to TTI for the measurement of breathing efforts. We hypothesize that non-invasive measurements of the diaphragm's electrical activity may be more accurate than current monitoring standards in detecting respiratory efforts 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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Group/Cohort Intervention/treatment
(1) 5 preterm infants spontaneously breathing in-room air with no respiratory support

Respiratory acoustic signals will be collected and compared with airflow measurements obtained using a pneumotachometer, i.e. the gold standard. Inclusion of these infants is necessary to demonstrate the reliability of the respiratory acoustic sensor in capturing airflow when compared to the gold standard pneumotachometer.

Data will be collected for 10 minutes.

Device: Respiratory Acoustic Sensor
The respiratory acoustic sensor detects acoustic breathing signals produced by the turbulent airflow in the upper chest that occurs during inspiration and expiration.
Other Name: TSD108A®, Biopac Systems Inc, Santa Barbara, CA, USA

(2) 10 preterm infants spontaneously breathing in-room air with no respiratory support

Respiratory acoustic signals will be collected and compared with airflow measurements obtained using a nasal temperature sensor. In addition, measurements of respiratory efforts will be obtained using respiratory inductive plethysmography, electrical activity of the diaphragm, and transthoracic impedance. The inclusion of these infants will allow for better description of the properties of the breath sounds in a stable cohort of infants, without interference from the CPAP noise.

Data will be collected for 3 hours.

Device: Respiratory Acoustic Sensor
The respiratory acoustic sensor detects acoustic breathing signals produced by the turbulent airflow in the upper chest that occurs during inspiration and expiration.
Other Name: TSD108A®, Biopac Systems Inc, Santa Barbara, CA, USA

Device: Electrical Activity of the diaphragm catheter
The EAdi catheter detects the electrical activity of the diaphragm
Other Name: EAdi Catheter, Maquet, Solna, Sweden

(3) 10 preterm infants on continuous positive airway pressure (CPAP) with cardiorespiratory events

Respiratory acoustic signals will be collected. In addition, measurements of respiratory efforts will be obtained using respiratory inductive plethysmography, electrical activity of the diaphragm, and transthoracic impedance. The inclusion of infants on CPAP will allow for detection of both breath sounds and airflow coming from the transmitted CPAP pressure in a cohort of infants at higher risk of cardiorespiratory events.

Data will be collected for 3 hours.

Device: Respiratory Acoustic Sensor
The respiratory acoustic sensor detects acoustic breathing signals produced by the turbulent airflow in the upper chest that occurs during inspiration and expiration.
Other Name: TSD108A®, Biopac Systems Inc, Santa Barbara, CA, USA

Device: Electrical Activity of the diaphragm catheter
The EAdi catheter detects the electrical activity of the diaphragm
Other Name: EAdi Catheter, Maquet, Solna, Sweden




Primary Outcome Measures :
  1. Accuracy of respiratory acoustics for the detection of airflow [ Time Frame: 10 minutes (group 1) or 3 hours (groups 2 and 3) ]
    The accuracy of respiratory acoustic monitoring will be compared against the current gold standard methods for measuring airflow (i.e. pneumotachometer or nasal temperature).


Secondary Outcome Measures :
  1. Accuracy of the electrical activity of the diaphragm for the detection of respiratory efforts [ Time Frame: 3 hours (groups 2 and 3 only) ]
    The accuracy of the electrical activity of the diaphragm will be compared against the current gold standard for monitoring respiratory efforts (i.e. respiratory inductive plethysmography)

  2. Accuracy of transthoracic impedance for the detection of respiratory efforts [ Time Frame: 3 hours (groups 2 and 3 only) ]
    The accuracy of transthoracic impedance will be compared against the current gold standard for monitoring respiratory efforts (i.e. respiratory inductive plethysmography)



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Ages Eligible for Study:   72 Hours and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196646


Contacts
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Contact: Wissam M Shalish, MD PhD 514-412-4400 ext 22341 wissam.shalish@mcgill.ca

Locations
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Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Contact: Wissam Shalish, MD, PhD    514-412-4400 ext 22341    wissam.shalish@mcgill.ca   
Principal Investigator: Wissam Shalish, MD PhD         
Sub-Investigator: Guilherme Sant'Anna, MD PhD         
Sub-Investigator: Robert E Kearney, PhD         
Sub-Investigator: Evelyn Constantin, MD         
Sub-Investigator: Larry Lands, MD         
Sub-Investigator: Marisa Leone, RT         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Université de Sherbrooke
Université de Montréal
Investigators
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Principal Investigator: Wissam M Shalish, MD PhD McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Wissam Shalish, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT05196646    
Other Study ID Numbers: 2022-7444
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wissam Shalish, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Airflow
Apnea
Cardiorespiratory events
Monitoring
Neonatal Intensive Care
Preterm infants
Respiratory acoustics
Prematurity
CPAP
Acoustic monitoring
diaphragm
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications