Airway pressure measurements in newborns on non-invasive respiratory support: a feasibility study (AIRPREMO 2 Study)
Pharyngeal pressure in newborns on non-invasive respiratory support: a feasibility study to assess a new airway pressure monitor (AIRPREMO 2 Feasibility Study)
The Royal Women's Hospital Melbourne
50 participants
Jan 15, 2025
Interventional
Conditions
Summary
While continuous positive airway pressure (CPAP) and high flow nasal cannula (HFNC) are commonly used for treatment of infants with respiratory distress, the optimal level of CPAP/HFNC remains somewhat uncertain. Due to leaks occurring at the nostrils, the mouth and into the stomach, not all of the pressure generated by CPAP/HFNC is transmitted to the airway. Continuous measurement of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a feasibility study to measure the pharyngeal pressure in a convenience sample of up to 50 infants receiving CPAP/HFNC for the purpose of confirming the performance and safety of a new airway monitoring device. TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the pharyngeal region using a new airway pressure device (under development). The modified gastric tube will be used similar to regular gastric tubes, and pharyngeal pressures recorded over a 3-8 day period. The modified gastric tube will enable study participants to be fed as per usual clinical guidelines and facilitate enteral fluids/medication delivery as clinically required.
Eligibility
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Interventions
In the AIRPREMO 2 Study, a modified TGA-approved dual-lumen gastric tube connected to a new external device will be used to measure the upper airway pressure (pharyngeal pressure) in newborns receiving non-invasive respiratory support (continuous positive airway pressure (CPAP) or high flow nasal cannula (HF)). Once inserted, the sensor lumen of the study feeding tube will be connected to a study sensor module unit which is connected to the study data acquisition unit (airway pressure monitor) that is positioned at the bedside. Pharyngeal pressure measurements will be obtained with the research data collection system for 3-8 days, with the data obtained from the study informing the development of a new device. Clinical staff will not have the ability to view the airway pressure data on the data acquisition unit unless shown by the research team. The primary feeding lumen of the gastric tube will enable study participants to be fed as per usual clinical guidelines and facilitate enteral fluids/medication delivery as clinically required. The duration of recoding can vary from 3 to 8 days as outlined in our research protocol and as per clinical practices for replacement of tubes. Enteral feeds for infants on respiratory support are administered intermittently and advance (in volume and frequency) as the infant’s tolerance of feeding increases.
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ACTRN12624001314516