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Deep oropharyngeal air pressure measurements in newborns on non-invasive respiratory support (AIRPREMO Study)

Pharyngeal pressure measurements in newborn babies on continuous positive airway pressure or high flow nasal cannulae (AIRPREMO Study)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000156684
Acronym
AIRPREMO (Airpressure Monitor) Study
Enrollment
30
Registered
2023-02-16
Start date
2023-03-14
Completion date
2024-09-18
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

While continuous positive airway pressure (CPAP) and high flow nasal cannulae (HFNC) are commonly used for treatment of infants with respiratory distress, the optimum 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. Real-time information of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a proof-of-concept observational study to measure the pharyngeal pressure in a convenience sample of 50 infants receiving CPAP/HFNC for the purpose of developing a novel airway pressure monitoring device. TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the deep oropharynx using a new airway pressure device (under development). The modified gastric tube will be inserted nasally or orally, similar to regular gastric tubes, and pressures recorded over a one-hour period .

Interventions

In the AIRPREMO Study, a modified TGA approved dual lumen nasogastric tube (initially only 8 French in size; after participant 16, with Ethics Committee approval, either 6 French or 8 French in size, depending on the participant's weight and as per preference of the clinical team) is used to measure deep oropharyngeal air pressure of babies who receive non-invasive respiratory support (either through continuous positive airway pressure or through high flow nasal cannulae). Measurements are obtai

In the AIRPREMO Study, a modified TGA approved dual lumen nasogastric tube (initially only 8 French in size; after participant 16, with Ethics Committee approval, either 6 French or 8 French in size, depending on the participant's weight and as per preference of the clinical team) is used to measure deep oropharyngeal air pressure of babies who receive non-invasive respiratory support (either through continuous positive airway pressure or through high flow nasal cannulae). Measurements are obtained with this research data collection system for up to one hour and data will inform the development of a new device.

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to 1 Years
Healthy volunteers
No

Inclusion criteria

Babies with a current weight of 1.5 kg or more treated at the Royal Women's Hospital Neonatal Intensive Care Unit receiving non-invasive respiratory support which is expected to be continued for at least one hour who are sufficiently stable for the study intervention as per assessment of the treating neonatal consultant

Exclusion criteria

Weight less than 1.5 kg Anatomical anomaly of the nose, mouth, palate, neck, nasal or pharyngeal airway

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026