A groundbreaking pilot study conducted at the Medical University of Vienna's tertiary NICU has demonstrated that respiratory function monitoring (RFM) can significantly improve the placement accuracy of supraglottic airway devices (SADs) in neonates, potentially revolutionizing airway management practices in newborn care.
The study, registered under ClinicalTrials ID NCT05512689, evaluated six neonates ranging from 30+5 weeks gestational age to 19 months, with weights between 1140g and 4405g. The research team utilized the iGel size 1 SAD combined with the Neo100 RFM system to measure critical ventilation parameters in real-time.
Clinical Outcomes and Performance Metrics
The results revealed a striking difference in placement success rates between visible and hidden RFM groups. When providers had access to real-time RFM feedback, they required a median of just one attempt for successful placement, compared to three attempts when the monitor was hidden. The average placement time for successful attempts was 18 seconds (range: 12-31 seconds).
"The RFM can be a great help to minimize the time until adaptations are made," noted the researchers, highlighting how the technology enables providers to make subtle but crucial adjustments to SAD positioning.
Technical Innovation and Validation
The study employed a novel approach to validate RFM accuracy by using bronchoscopy to confirm proper SAD placement. The research team found that low leakage values (<30%) displayed on the RFM consistently corresponded with correct anatomical positioning around the larynx, as verified through endoscopic visualization.
Ventilation data showed significant improvements when RFM guidance was available:
- Initial high leakage rates (93.3% and 56.3%) in patients without visible RFM
- Median leakage of 17.6% in patients with visible RFM
- Successful leakage reduction after position optimization (e.g., 75.6% to 18.8% in one case)
Implications for Smaller Patients
Particularly noteworthy was the successful application in infants under 1500g, a population where SAD use has limited evidence. The study demonstrated that even in a 1140g infant, successful placement was achieved in a single attempt when using RFM guidance, compared to four attempts needed in a slightly larger infant without RFM visualization.
Future Applications and Clinical Impact
The findings suggest potential applications beyond routine care, including:
- Support during emergency resuscitations in delivery rooms
- Guidance during surfactant administration procedures (SALSA technique)
- Training and skill development for healthcare providers
While the researchers acknowledge the study's limited sample size, these preliminary results point toward a promising direction for improving neonatal airway management safety and efficiency. The combination of SAD and RFM technology could particularly benefit less experienced providers and complex cases involving extremely low birth weight infants.
