Objective: T-piece resuscitation systems are pressure unstable and have high imposed work of breathing (iWOB). Pressure stable respiratory support with low iWOB might improve outcome. We have developed a new resuscitation system that can be used with nasal prongs or face mask. The aim of the study was to describe the in vitro performance of the new system and to perform a clinical feasibility trial of initial stabilisation of preterm infants. Method: A mechanical lung model was used to determine iWOB at increasing levels of continuous positive airway pressure (CPAP). The feasibility trial included 36 infants (27–34 weeks of gestation), who were randomised into three groups (T-piece, new system with face mask or new system with prongs). Collected data included problems with usage, safety, time to stable breathing, need for positive pressure ventilation and intubation. Results: In the mechanical lung model, the new system reduced iWOB with 91.5% (mask) and 86.6% (medium prongs) compared with Neopuff (4 cm CPAP, p<0.001). Informed consent was obtained from 45 patients, 39 were randomised and 36 needed support. Randomisation resulted in an imbalance: The group of new system infants had lower gestational age compared with the T-piece group. Thirteen patients needed positive pressure ventilation (median 20 cm H₂O). One infant was intubated. The study did not reveal problems with the equipment or safety. Conclusions: Compared with T-piece systems, the new system had a marked reduction in iWOB in bench tests. The feasibility trial did not reveal problems with usability or safety.

Background The original bubble continuous positive airway pressure (bCPAP) design has wide-bore tubing and a low-resistance interface. This creates a stable airway pressure that is reflected by the submersion depth of the expiratory tubing. Several systems with alterations to the original bCPAP design are now available. Most of these are aimed for use in low-income and middle-income countries and have not been compared with the original design. Objective We identified three major alterations to the original bCPAP design: (1) resistance of nasal interface, (2) volume of dead space and (3) diameter of expiratory tubing. Our aim was to study the effect of these alterations on CPAP delivery and work of breathing in a mechanical lung model. Dead space should always be avoided and was not further tested. Methods The effect of nasal interface resistance and expiratory tubing diameter was evaluated with simulated breathing in a mechanical lung model without interface leakage. The main outcome was delivered CPAP and imposed work of breathing. Results High-resistance interfaces and narrow expiratory tubing increased the work of breathing. Additionally, narrow expiratory tubing resulted in higher CPAP levels than indicated by the submersion depth. Conclusion Our study shows the significant effect on CPAP delivery and imposed work of breathing when using high-resistance interfaces and narrow expiratory tubing in bCPAP systems. New systems should include low-resistance interfaces and wide-bore tubing and be compared with the original bCPAP. Referring to all systems that bubble as bCPAP is misleading and potentially hazardous.

Continuous positive airway pressure is an established treatment for respiratory distress in neonates. Continuous positive airway pressure has been applied to infants using an array of devices. The aim of this experimental study was to investigate the characteristics of seven continuous positive airway pressure systems using simulated breath profiles from newborns. Experimental in vitro study. Research laboratory in Sweden. None. In vitro simulation of spontaneous neonatal breathing was achieved with a mechanical lung model. Simulation included two breath profiles, three levels of continuous positive airway pressure with and without short binasal prongs and different levels of constant leak. Pressure stability and imposed work of breathing were determined. Seven continuous positive airway pressure systems were tested. There were large differences in pressure stability and imposed work of breathing between tested continuous positive airway pressure systems. Neopuff and Medijet had the highest pressure instability and imposed work of breathing. Benveniste, Hamilton Universal (Arabella), and Bubble continuous positive airway pressure showed intermediate results. AirLife and Infant Flow had the lowest pressure instability and imposed work of breathing. AirLife and Infant Flow showed the least decrease in delivered pressure when challenged with constant leak. The seven tested continuous positive airway pressure systems showed large variations in pressure stability and imposed work of breathing. They also showed large differences in how well they maintain continuous positive airway pressure when exposed to leak. For most systems, imposed work of breathing increased with increasing continuous positive airway pressure level. The clinical importance of the difference in pressure stability is uncertain. Our results may facilitate the design of clinical studies examining the effect of pressure stability on outcome.

Access to inexpensive respiratory support to newborn infants improves survival in low-income countries. Standard bubble continuous positive airway pressure (CPAP) has been extensively used worldwide for more than 30 years. One project aimed at providing affordable CPAP is the Pumani system developed by Rice 360°. Compared to standard bubble CPAP the system has an unconventional design. The aim was to compare the Pumani system with two traditional bubble CPAP systems, focusing on in-vitro performance and safety. The Pumani system was compared to traditional bubble CPAP from Fisher & Paykel (Auckland, New Zealand) and Diamedica (Devon, United Kingdom). The systems were tested using static flow resistance and simulated breathing for a range of fresh gas flows and submersion levels. There were large differences between the Pumani CPAP and the conventional bubble CPAP systems. The Pumani system was not pressure stable, had high resistance and high imposed work of breathing. It was not possible to use submersion depth to adjust CPAP without accounting for fresh gas flow. The Pumani design is novel and not similar to any previously described CPAP system. The main mechanism for CPAP generation was resistance, not submersion depth. The system should therefore not be referred to as bubble CPAP. The clinical consequences of its pressure instability and high imposed work of breathing are not known and trials on outcome and safety are needed.

Objective To determine leakage for two neonatal continuous positive airway pressure (CPAP) interfaces and evaluate leak-corrective manoeuvres. Design The ToNIL (Trial of NCPAP Interface Leakage) study was a randomised, clinical, cross-over trial with data collection between August 2018 and October 2019. The primary outcome was blinded to the treating staff. Setting One secondary, 8-bed neonatal intensive care unit (NICU) and three larger (>15 beds), academic NICU referral centres. Patients Newborn infants with CPAP were screened (n=73), and those with stable spontaneous breathing, low oxygen requirement, postmenstrual age (PMA) over 28 weeks and no comorbidities were eligible. In total, 50 infants were included (median PMA 33 completed weeks). Interventions Leakage was measured for both prongs and nasal mask, before and after leak-corrective manoeuvres. Interface application was performed in a randomised order by a nurse, blinded to the measured leakage. Main outcome measures 30 s average leakage, measured in litres per minute (LPM). Results Analyses showed a significantly lower leakage (mean difference 0.86 LPM, 95% CI 0.07 to 1.65) with prongs (median 2.01 LPM, IQR 1.00–2.80) than nasal mask (median 2.45 LPM, IQR 0.99–5.11). Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54–1.87) and nasal mask (median 2.35 LPM, IQR 0.76–4.75). Conclusions Large leakages were common for both interfaces, less with prongs. Simple care manoeuvres reduced leakage for both interfaces. This is the first report of absolute leakage for nasal interfaces and should encourage further studies on leakage during CPAP treatment.

Nasal continuous positive airway pressure (NCPAP) is an established treatment for respiratory distress in neonates. Most modern ventilators are able to provide NCPAP. There have been no large studies examining the properties of NCPAP delivered by ventilators. The aim of this study was to compare pressure stability and imposed work of breathing (iWOB) for NCPAP delivered by ventilators using simulated neonatal breathing. Experimental in vitro study. Research laboratory in Sweden. None. Neonatal breathing was simulated using a mechanical lung simulator. Seven ventilators were tested at different CPAP levels using two breath profiles. Pressure stability and iWOB were determined. Results from three ventilators revealed that they provided a slight pressure support. For these ventilators, iWOB could not be calculated. There were large differences in pressure stability and iWOB between the tested ventilators. For simulations using the 3.4-kg breath profile, the pressure swings around the mean pressure were more than five times greater, and iWOB more than four times higher, for the system with the highest measured values compared with the system with the lowest. Overall, the Fabian ventilator was the most pressure stable system. Evita XL and SERVO-i were found more pressure stable than Fabian in some simulations. The results for iWOB were in accordance with pressure stability for systems that allowed determination of this variable. Some of the tested ventilators unexpectedly provided a minor degree of pressure support. In terms of pressure stability, we have not found any advantages of ventilators as a group compared with Bubble CPAP, Neopuff, and variable flow generators that were tested in our previous study. The variation between individual systems is great within both categories. The clinical importance of these findings needs further investigation.