The LeVe CPAP System for Oxygen-Efficient CPAP Respiratory Support: Development and Pilot Evaluation.

Background: The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed a significant demand on healthcare providers (HCPs) to provide respiratory support for patients with moderate to severe symptoms. Continuous Positive Airway Pressure (CPAP) non-invasive ventilation can help patients with moderate symptoms to avoid the need for invasive ventilation in intensive care. However, existing CPAP systems can be complex (and thus expensive) or require high levels of oxygen, limiting their use in resource-stretched environments. Technical Development + Testing: The LeVe ("Light") CPAP system was developed using principles of frugal innovation to produce a solution of low complexity and high resource efficiency. The LeVe system exploits the air flow dynamics of electric fan blowers which are inherently suited to delivery of positive pressure at appropriate flow rates for CPAP. Laboratory evaluation demonstrated that performance of the LeVe system was equivalent to other commercially available systems used to deliver CPAP, achieving a 10 cm H2O target pressure within 2.4% RMS error and 50-70% FiO2 dependent with 10 L/min oxygen from a commercial concentrator. Pilot Evaluation: The LeVe CPAP system was tested to evaluate safety and acceptability in a group of ten healthy volunteers at Mengo Hospital in Kampala, Uganda. The study demonstrated that the system can be used safely without inducing hypoxia or hypercapnia and that its use was well-tolerated by users, with no adverse events reported. Conclusions: To provide respiratory support for the high patient numbers associated with the COVID-19 pandemic, healthcare providers require resource efficient solutions. We have shown that this can be achieved through frugal engineering of a CPAP ventilation system, in a system which is safe for use and well-tolerated in healthy volunteers. This approach may also benefit other respiratory conditions which often go unaddressed in Low and Middle Income Countries (LMICs) for want of context-appropriate technology designed for the limited oxygen resources available.

Effects of ultrasound modes on mandibular osteodistraction.

Previous studies have shown that therapeutic pulsed ultrasound (pulsed) has superior stimulatory effect on bone fracture healing compared with continuous ultrasound (continuous). Our predictive hypothesis was that pulsed ultrasound can produce better bone formation during mandibular osteodistraction than continuous ultrasound. Thirty-six New Zealand rabbits were divided into 3 groups of 12. Osteodistraction was performed at 3 mm/day for 5 days. Group 1 received pulsed, group 2 received continuous ultrasound, and group 3 was the control group (distraction only). Bone formation was assessed by quantitative bone density (QBD), mechanical testing, and histological examination. In the first 2 wks post-distraction, group 2 showed enhanced bone formation more than group 1 (p < 0.05); however, in the 3rd and 4th wks, group 1 showed more bone formation than group 2 (p < 0.05). Earlier stages of bone healing were enhanced more by continuous, whereas late stages were enhanced more by pulsed, ultrasound.

Experimental and Computational Models for Simulating Sound Propagation Within the Lungs.

An acoustic boundary element model is used to simulate sound propagation in the lung parenchyma and surrounding chest wall. It is validated theoretically and numerically and then compared with experimental studies on lung-chest phantom models that simulate the lung pathology of pneumothorax. Studies quantify the effect of the simulated lung pathology on the resulting acoustic field measured at the phantom chest surface. This work is relevant to the development of advanced auscultatory techniques for lung, vascular, and cardiac sounds within the torso that utilize multiple noninvasive sensors to create acoustic images of the sound generation and transmission to identify certain pathologies.

Boundary element model for simulating sound propagation and source localization within the lungs.

An acoustic boundary element (BE) model is used to simulate sound propagation in the lung parenchyma. It is computationally validated and then compared with experimental studies on lung phantom models. Parametric studies quantify the effect of different model parameters on the resulting acoustic field within the lung phantoms. The BE model is then coupled with a source localization algorithm to predict the position of an acoustic source within the phantom. Experimental studies validate the BE-based source localization algorithm and show that the same algorithm does not perform as well if the BE simulation is replaced with a free field assumption that neglects reflections and standing wave patterns created within the finite-size lung phantom. The BE model and source localization procedure are then applied to actual lung geometry taken from the National Library of Medicine's Visible Human Project. These numerical studies are in agreement with the studies on simpler geometry in that use of a BE model in place of the free field assumption alters the predicted acoustic field and source localization results. This work is relevant to the development of advanced auscultatory techniques that utilize multiple noninvasive sensors to construct acoustic images of sound generation and transmission to identify pathologies.

Pneumothorax detection using pulmonary acoustic transmission measurements.

Pneumothorax is a common clinical condition that can be life threatening. The current standard of diagnosis includes radiographic procedures that can be costly and may not always be readily available or reliable. The objective of this study was to investigate the hypothesis that pneumothorax causes detectable pathognomonic changes in pulmonary acoustic transmission. An animal model was developed whereby 15 mongrel dogs were anaesthetised, intubated and mechanically ventilated. A thoracoscopic trocar was placed into the pleural space for the introduction of air and confirmation of a approximately 30% pneumothorax by direct visualisation. Broadband acoustic signals were introduced into the endotracheal tube, while transmitted waves were measured at the chest surface. Pneumothorax was found consistently to lower the pulmonary acoustic transmission in the 200-1200 Hz frequency band, whereas smaller transmission changes occurred at lower frequencies (p< 0.0001, sign test). The ratio of acoustic energy between low-(< 220 Hz) and high-(550-770 Hz) frequency bands was significantly different in the control and pneumothorax states (p < 0.0001, sign test). This implies that pneumothoraces can be reliably detected using pulmonary acoustic transmission measurements in the current animal model. Further studies are needed to investigate the feasibility of using this technique in humans.

Pneumothorax detection using computerised analysis of breath sounds.

The primary objective of the study was to investigate the effects of pneumothorax (PTX) on breath sounds and to evaluate their use for PTX diagnosis. The underlying hypothesis is that there are diagnostic breath sound changes with PTX. An animal model was created in which breath sounds of eight mongrel dogs were acquired and analysed for both normal and PTX states. The results suggested that pneumothorax was associated with a reduction in sound amplitude, a preferential decrease in high-frequency acoustic components and a reduction in sound amplitude variation during the respiration cycle (p<0.01 for each, using the Wilcoxson signed-rank test). Although the use of diminished sound amplitude for PTX diagnosis assumes availability of baseline measurements, this appears unnecessary for high-frequency reduction or sound amplitude changes over the respiratory cycle. Further studies are warranted to test the clinical feasibility of the method in humans.

Use of abdominal percussion for pneumoperitoneum detection.

Pneumoperitoneum refers to free air within the abdominal cavity that typically signifies serious abdominal pathology such as a perforated gut. The principal hypothesis of the study was that abdominal structure alterations due to pneumoperitoneum cause diagnostic changes in the sounds induced by abdominal percussion. The current pilot study investigated these changes in a mongrel dog model. Abdominal percussion was performed at baseline and after creation of pneumoperitoneum states. The resulting acoustic events were acquired, digitised and analysed. The event attack and decay rates and dominant frequencies during decay decreased with pneumoperitoneum (p = 0.084, 0.014 and 0.004, respectively; Wilcoxon signed-rank test). Simple theoretical models were constructed and predicted the observed decrease in resonant frequencies with increasing air pocket size. The results suggested that the normal and the 1,000 ml pneumoperitoneum states can be separated using thresholds of the attack and decay rates and resonant frequency (specificity = 80%, 100% and 100%, and sensitivity = 100%, 100% and 100%, respectively). Separating the control and the 500 ml pneumoperitoneum cases may be also possible (specificity = 80%, 100%, 100% and sensitivity = 50%, 70% and 90%, respectively), but separating the two levels of pneumoperitoneum was not feasible using the current approach. Therefore analysis of abdominal percussion sounds may prove useful for pneumoperitoneum detection, but not for distinguishing different levels of that condition.

Modeling sound transmission through the pulmonary system and chest with application to diagnosis of a collapsed lung.

A theoretical and experimental study was undertaken to examine the feasibility of using audible-frequency vibro-acoustic waves for diagnosis of pneumothorax, a collapsed lung. The hypothesis was that the acoustic response of the chest to external excitation would change with this condition. In experimental canine studies, external acoustic energy was introduced into the trachea via an endotracheal tube. For the control (nonpneumothorax) state, it is hypothesized that sound waves primarily travel through the airways, couple to the lung parenchyma, and then are transmitted directly to the chest wall. In contradistinction, when a pneumothorax is present the intervening air presents an added barrier to efficient acoustic energy transfer. Theoretical models of sound transmission through the pulmonary system and chest region to the chest wall surface are developed to more clearly understand the mechanisms of intensity loss when a pneumothorax is present, relative to a baseline case. These models predict significant decreases in acoustic transmission strength when a pneumothorax is present, in qualitative agreement with experimental measurements. Development of the models, their extension via finite element analysis, and comparisons with experimental canine studies are reviewed.

Vibratory coherence as an alternative to radiography in assessing bone healing after osteodistraction.

Distraction osteogenesis is used in orthopedics to lengthen bones by cutting or breaking the bone and gradually separating the two pieces as new bone fills the intervening space. There is a need for early assessment of the degree of bone healing that allows for normal functioning without unwanted side effects. This study compared different techniques used to evaluate the degree of bone healing during mandibular osteodistraction in 21 rabbits. For each rabbit, the mandible was cut in a surgical procedure and then 72 h later distraction began at a rate of 3 mm per day. Bone formation at the distraction site was assessed by in vivo photodensitometry on head radiographs, an in vivo (nondestructive) vibratory coherence test across the distraction site, a postmortem, ex vivo (destructive) three-point bending mechanical test, and by postmortem, ex vivo (destructive) histological examination. Statistical analyses included analysis of variance and correlation coefficient tests. The findings revealed that the results of bone photodensity and the mechanical three-point test are highly and positively correlated with the results of the vibration test. The use of the vibration test may provide a substitute for or augment the routine use of radiography for in vivo evaluation and monitoring of bone healing.

Acoustic characteristics of air cavities at low audible frequencies with application to pneumoperitoneum detection.

Air accumulations within living organisms are sometimes pathologic. An example is free air within the abdomen from perforation of the intestines (a condition called pneumoperitoneum). The objectives of the described research were to define the acoustic signatures of abdominal air cavities at low frequencies and to investigate the feasibility of using these signatures for pneumoperitoneum diagnosis. The central hypothesis was that low-frequency vibro-acoustic property changes are detectable using broad-band acoustic excitation applied at the abdominal surface. Band-limited white noise (0-3200 Hz) was introduced at the abdominal surface of sedated dogs and response was measured by a surface vibro-acoustic sensor. The transfer function and coherence were estimated from these measurements. The presence of pneumoperitoneum caused increased resonances and anti-resonances (p < 0.01). Measures of the latter parameters were proposed and evaluated to quantitatively measure their magnitude. Resonant spectral peaks of more than 3 dB were consistent with pneumoperitoneum (p < 0.01), and both resonance and anti-resonance increased with condition severity (p < 0.03). The data also suggest a possible reduction in the resonant and anti-resonant frequencies with decreasing air cavity volumes (p = 0.14) as supported by theoretical predictions. Finally, anti-resonance was also found to be associated with a drop in coherence. These findings suggest that the proposed technique may be useful in the diagnosis of pneumoperitoneum.

Radiation impedance of a finite circular piston on a viscoelastic half-space with application to medical diagnosis.

In a recent study a new analytical solution was developed and validated experimentally for the problem of surface wave generation on a linear viscoelastic half-space by a rigid circular disk located on the surface and oscillating normal to it. The results of that study suggested that, for the low audible frequency range, some previously reported values of shear viscosity for soft biological tissues may be inaccurate. Those values were determined by matching radiation impedance measurements with theoretical calculations reported previously. In the current study, the sensitivity to shear viscoelastic material constants of theoretical solutions for radiation impedance and surface wave motion are compared. Theoretical solutions are also compared to experimental measurements and numerical results from finite-element analysis. It is found that, while prior theoretical solutions for radiation impedance are accurate, use of such measurements to estimate shear viscoelastic constants is not as precise as the use of surface wave measurements.

Excitation and propagation of surface waves on a viscoelastic half-space with application to medical diagnosis.

An analytical solution is developed for the problem of surface wave generation on a linear viscoelastic half-space by a finite rigid circular disk located on the surface and oscillating normal to it. The solution is an incremental advancement of theoretical work reported in articles focused on seismology. Since the application of interest here is medical diagnostics, the solution is verified experimentally using a viscoelastic phantom with material properties comparable to biological soft tissue. Findings suggest that prior estimates in the literature of the shear viscosity in human soft tissue may not be accurate in the low audible frequency range. Measurement of wave motion on the skin surface caused by internal biological functions or external stimuli has been studied by a few researchers for rapid, nonintrusive diagnosis of a variety of specific medical ailments. It is hoped that the developments reported here will advance these techniques and also provide insight into related diagnostic methods, such as sonoelastic imaging and other methodologies that utilize disease-related variations in tissue shear elasticity or variations in density due to gaseous inclusions.