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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP 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 main goals are:
Continuous positive airway pressure (CPAP) is an essential, non-invasive therapy for treating various respiratory conditions in the Neonatal Intensive Care Units (NICU). CPAP is an effective treatment for respiratory distress syndrome, apneas, or after extubation, exerting its physiological benefits by maintaining upper airway patency and functional residual capacity. Bubble CPAP (bCPAP) is the most widely used CPAP due to its low cost and ease of use. It consists of an inspiratory tube carrying heated and humidified air, a nasal interface, and an expiratory tube immersed in a water chamber. The generation of bubbles in the water chamber by exhaled gas creates low amplitude and high-frequency pressure oscillations that are transmitted back to the chest. Successful CPAP requires constant transmission of the pressure via an unobstructed circuit. However, this is difficult to achieve in practice due to inadequate interface, leaks from an open mouth, and obstructed airway. As a result, bCPAP requires frequent manual checks by nurses and respiratory therapists to ensure that the circuit is secure and unobstructed.
As a proposed solution, bCPAP sounds heard in the patient room or upon auscultation are routinely used to assess the effectiveness of CPAP therapy. This sound can be heard both from the water tank creating the vibrations and during auscultation with a stethoscope, as the sound vibration is transmitted to the neonatal lungs. In the current era of digital technology, acoustic sounds can be converted to electronic signals for further processing and analysis.
We hypothesize that continuous recording and analysis of bCPAP sounds could be used as a proxy for real-time objective monitoring of the pressure transmitted to infants' lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) | Group 1 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded for 3 hours. To do so, we will use a standard microphone placed on the water tank and an external pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. |
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| Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) | Group 2 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded. To do so, we will use a standard microphone placed on the water tank and a pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. In addition, the internal bubble CPAP sound and pressure transmitted to the infant's lungs will be measured. For these, a wireless acoustic sensor will be secured on the infant's suprasternal notch to capture transmitted CPAP sounds, and an internal pressure transducer will be inserted from the infant's mouth into the nasopharynx to record the pressure delivered in the airway. Data will be recorded for 3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External pressure transducer | Device | The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure | The mean pressure and the standard deviation of the pressure will be computed for each segment. | 3 hours |
| External bubble CPAP sounds | Two metrics will be computed:
| 3 hours |
| Internal bubble CPAP sounds |
| 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wissam Shalish, MD, PhD | Contact | 514-412-4400 | 22341 | wissam.shalish@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Wissam Shalish, MD PhD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Standard microphone | Device | The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip. |
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| Wireless acoustic sensor | Device | The wireless acoustic sensor contains a dual microphone capable of capturing target sounds as well as ambient noise. The frequencies associated with ambient noise will be subtracted to maximize the signal-to-noise ratio of the bubble sound waveform. The wireless sensor will be placed on the suprasternal notch of the infant for monitoring the bubble sounds transmitted to the lungs and secured using a silicone-based tape approved for use in neonates. Data will be transmitted in real-time to a research-dedicated tablet using the Bluetooth Communication Controller and stored for future analysis. |
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| Internal pressure transducer | Device | The transmitted CPAP pressure will be measured using an ultra-thin, single-use catheter pressure transducer inserted through the mouth to the level of the infant's nasopharynx. The data will be acquired with a sampling rate of 10kHz and stored for later analysis. |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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