A Novel CPAP Device With an Integrated Oxygen Concentrator for Low Resource Countries: In Vitro Validation and Usability Test in Field.

Goal: To develop and validatea novel neonatal non-invasive respiratory support device prototype designed to operate in low-resource settings. Methods: The device integrates a blower-based ventilator and a portable oxygen concentrator. A novel control algorithm was designed to achieve the desired fraction of inspired oxygen (FiO2) while minimizing power consumption. The accuracy of the delivered FiO2 and the device power consumption were evaluated in vitro, and a formative usability test was conducted in a rural hospital in Uganda. Results: The agreement between the set and delivered FiO2 was high (limit of agreement:-5.6 ÷ 3.8%). For FiO2 below 60%, the control algorithm reduced the power drain by 50%. The device was also appreciated by intended users. Conclusion: The prototype proved effective in delivering oxygen-enriched continuous positive airway pressure in the absence of compressed air and oxygen, holding promise for a sustainable and effective implementation of neonatal respiratory support in low-resource settings.

Early respiratory system reactance predicts respiratory outcomes in preterm infants: a retrospective, multicentre study.

OBJECTIVE: This multicenter, international, retrospective study aims to investigate whether respiratory system reactance (Xrs) assessed by respiratory oscillometry on the 7th day of life is associated with respiratory outcomes in preterm infants below 32 weeks' gestation. METHODS: Sinusoidal pressure oscillations (2-5 cmH2O peak-to-peak, 10 Hz) were superimposed on the positive end-expiratory pressure (PEEP). We assessed the association of Xrs z-score with the duration of respiratory support using linear regression and with bronchopulmonary dysplasia (BPD, according to Jensen et al. 2019) using logistic regression. We used the likelihood ratio test to evaluate whether Xrs z-score adds significantly to clinical predictors, including gestational age (GA), birth weight (BW) and the National Institute of Child Health and Human Development (NICHD) BPD prediction model. RESULTS: One hundred and thirty-seven infants (median (Q1, Q3) GA=28.43 (26.11, 30.29) weeks) were included; 44 (32%) developed BPD. Xrs z-score was significantly associated with the duration of respiratory support (R2=0.35). Xrs z-score was significantly higher in infants who developed BPD (p<0.001); the optimal cut-off value was 2.6, associated with 77% sensitivity and 80% specificity. In univariable analysis, per z-score increase in Xrs, the OR for BPD increased by 60% and the respiratory support by eight days. In multivariable analysis, Xrs z-score added significantly to the NICHD model and to GA and BW z-score to predict respiratory support duration (p=0.016 and p=0.014, respectively) and BPD development (p=0.003 and p<0.001, respectively). CONCLUSION: Xrs z-score on the 7th day after birth improves the prediction of respiratory outcome in preterm infants.

Effect of different lung recruitment strategies and airway device on oscillatory mechanics in children under general anaesthesia.

BACKGROUND: Atelectasis has been reported in 68 to 100% of children undergoing general anaesthesia, a phenomenon that persists into the recovery period. Children receiving recruitment manoeuvres have less atelectasis and fewer episodes of oxygen desaturation during emergence. The optimal type of recruitment manoeuvre is unclear and may be influenced by the airway device chosen. OBJECTIVE: We aimed to investigate the different effects on lung mechanics as assessed by the forced oscillation technique (FOT) utilising different recruitment strategies: repeated inflations vs. one sustained inflation and different airway devices, a supraglottic airway device vs. a cuffed tracheal tube. DESIGN: Pragmatic enrolment with randomisation to the recruitment strategy. SETTING: We conducted this single-centre trial between February 2020 and March 2022. PARTICIPANTS: Seventy healthy patients (53 boys) aged between 2 and 16 years undergoing general anaesthesia were included. INTERVENTIONS: Forced oscillations (5 Hz) were superimposed on the ventilator waveform using a customised system connected to the anaesthesia machine. Pressure and flow were measured at the inlet of the airway device and used to compute respiratory system resistance and reactance. Measurements were taken before and after recruitment, and again at the end of surgery. MAIN OUTCOME MEASURES: The primary endpoint measured is the change in respiratory reactance. RESULTS: Statistical analysis (linear model with recruitment strategy and airway device as factors) did not show any significant difference in resistance and reactance between before and after recruitment. Baseline reactance was the strongest predictor for a change in reactance after recruitment: prerecruitment Xrs decreased by mean (standard error) of 0.25 (0.068) cmH 2 O s l -1 per  1 cmH 2 O -1  s l -1 increase in baseline Xrs ( P  < 0.001). After correcting for baseline reactance, the change in reactance after recruitment was significantly lower for sustained inflation compared with repeated inflation by mean (standard error) 0.25 (0.101) cmH 2 O ( P  = 0.0166). CONCLUSION: Although there was no significant difference between airway devices, this study demonstrated more effective recruitment via repeated inflations than sustained inflation in anaesthetised children. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619001434189.

Relationship between oscillatory volume and oscillatory pressure in neonatal high-frequency oscillatory ventilators: an in vitro study.

OBJECTIVE: We analysed the relationship between oscillatory volume (VOSC) and pressure amplitude (ΔP) in six neonatal high-frequency oscillatory (HFO) ventilators and related it to (1) the accuracy of VOSC and ΔP measurements and (2) the maximal delivered ΔP. DESIGN: In vitro study. SETTING: Neonatal intensive care unit. INTERVENTIONS: Ventilators tested were VN800 (Dräger), Servo-n (Maquet Getinge), SensorMedics 3100A (Vyaire Medical), Fabian HFOi (Vyaire Medical), SLE6000 (SLE UK) and Humming Vue (Metran). We changed various settings and mechanical characteristics of the test lung to mimic preterm and term conditions. MAIN OUTCOME MEASURES: For each condition, we measured VOSC and ΔP. We assessed the accuracy of the VOSC and ΔP measurements versus a reference measurement system using linear regression and Bland-Altman analysis. We evaluated the maximum delivered ΔP at different oscillatory frequencies. RESULTS: We observed large variability between machines in the ΔP displayed at any target VOSC. Most ventilators over-read ΔP with errors up to 30 cmH2O or 60%. The error in the measurement of VOSC was up to ±2 mL or ±30%. We observed high variability in the accuracy of ΔP and VOSC measurements; the SLE6000 committed the lowest errors in ΔP measurements and the Fabian HFOi in VOSC. The maximum delivered ΔP varied depending on the ventilator, being maximal for the Humming Vue, followed by the SLE6000 and SensorMedics 3100A. CONCLUSIONS: The variability in the relationship between VOSC and ΔP among HFO ventilators is largely explained by the variable accuracy in ΔP and VOSC measurement. Different ventilators also exhibit important differences in the maximal generated ΔP.

Hemodynamic evaluation in preterm infants using ultrasonic cardiac output monitor (USCOM).

We aimed to establish reference ranges for USCOM parameters in preterm infants, determine factors that affect cardiac output, and evaluate the measurement repeatability. This retro-prospective study was performed at Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy. We included infants below 32 weeks of gestational age (GA) and/or 1500 g of birth weight (BW). We excluded infants with congenital heart diseases or hemodynamic instability. Measurements were performed at 3 ± 1, 7 ± 2, and 14 ± 2 postnatal days. We analyzed 204 measurements from 92 patients (median GA = 30.57 weeks, BW = 1360 g). The mean (SD) cardiac output (CO) was 278 (55) ml/min/kg, cardiac index (CI) was 3.1 (0.5) L/min/m2, and systemic vascular resistance (SVRI) was 1292 (294) d*s*cm-5/m2. CO presented a negative correlation with postmenstrual age (PMA), while SVRI presented a positive correlation with PMA. The repeatability coefficient was 31 ml/kg/min (12%).  Conclusion: This is the first study describing reference values for USCOM parameters in hemodynamically stable preterm infants and factors affecting their variability. Further studies to investigate the usefulness of USCOM for the longitudinal assessment of patients at risk for cardiovascular instability or monitoring the response to therapies are warranted. What is Known: • The ultrasonic cardiac output monitoring (USCOM) has been widely used on adult and pediatric patients and reference ranges for cardiac output (CO) by USCOM have been established in term infants. What is New: • We established reference values for USCOM parameters in very preterm and very-low-birth-weight infants; the reference ranges for CO by USCOM in the study population were 198-405 ml/kg/min. • CO normalized by body weight presented a significant negative correlation with postmenstrual age (PMA); systemic vascular resistance index presented a significant positive correlation with PMA.