Extremely premature infants are at a high risk for brain damage. Researchers at the University of Vienna and the Medical University of Vienna have now found possible targets for the early treatment of such damage outside the brain: Bacteria in the gut of premature infants.
For the first time, researchers at the Technical University of Munich (TUM) have successfully used a new X-ray method for respiratory diagnostics with patients. Dark-field X-rays visualize early changes in the alveolar structure caused by the lung disease COPD and require only one fiftieth of the radiation dose typically applied in X-ray computed tomography. This permits broad medical application in early detection and treatment follow-up of respiratory ailments.
There are millions of cases in which serious respiratory system illnesses place limitations on quality of life. Every year more than four million people die of serious respiratory ailments worldwide. Partially destroyed alveoli and an over-inflation of the lungs (emphysema) are typical of the life-threatening ailment Chronic Obstructive Pulmonary Disease (COPD).
However, the fine distinctions between healthy and diseased tissue are barely visible on conventional chest X-rays. Detailed diagnostic information is only available using three-dimensional computed tomography approaches, in which the computer assembles many individual images. Until now there has been no fast and cost-effective option for early detection and follow-up examinations with a low radiation exposure as used in plain chest X-rays.
A procedure developed at the Technical University of Munich could now fill this gap: dark-field chest X-rays. In the November 1, 2021 issue of The Lancet Digital Health a research team led by Franz Pfeiffer, Professor for Biomedical Physics and Director of the Munich Institute of Biomedical Engineering at TUM, present the results of an initial clinical patient study, which used the new X-ray technology for the diagnosis of the lung disease COPD.
Conventional X-ray imaging is based on the attenuation of X-rays on their way through the tissue. Dark-field technology on the other hand use the wave nature of X-ray light, which is discarded in conventional X-ray imaging.
The new method thus uses the physical phenomenon of scattering in a manner similar to the long-known principle of dark-field microscopy with visible light. This allows to visualize the structure of objects that are for the most part transparent. These structures appear in the microscope as bright images on a dark background, which has given the method its name.
“The X-ray dark-field signal is particularly strong for interfaces between air and tissue,” Prof. Pfeiffer points out. “This makes it possible for a dark-field X-ray image of the lung to clearly distinguish between intact alveoli, i.e. those filled with air, and regions in which less intact alveoli exist.”
The dark field X-ray method visualizes early changes in the alveolar structure as a result of the lung disease COPD. Franz Pfeiffer, Professor for Biomedical Physics, hopes that this will significantly improve the early detection of lung diseases.
In addition, an examination using dark-field chest X-ray technology involves a significantly lower radiation dose than presently used computed tomography. This is because dark-field chest X-rays require only one exposure per patient, as compared to the large number of individual images taken from different directions which are necessary in computed tomography.
“We expect the radiation exposure to be reduced by a factor of fifty,” says Prof. Pfeiffer. Furthermore, the first clinical results have confirmed that the dark-field X-rays provide additional image information on the underlying microstructure of the lung.
“Given the close connection between the alveolar structure and the functional condition of the lung, this ability is of great significance for pulmonary medicine,” explains Dr. Alexander Fingerle, senior physician at TUM’s university hospital Klinikum rechts der Isar’s Department of Diagnostic and Interventional Radiology. “In the future dark-field X-rays could help improve early detection of COPD and other respiratory ailments.”
Prof. Pfeiffer hopes these initial clinical results with patients will accelerate the execution of further clinical studies and the development of marketable devices that use the dark-field method.
“Dark-field chest X-rays are currently giving us a chance to significantly improve the early detection of lung diseases and at the same time to implement it on a wider basis than before,” Prof Pfeiffer notes.
Since dark-field imaging is not limited to COPD, further translational studies with other pulmonary pathologies such as pulmonary fibrosis, pneumothorax, lung cancer and pneumonia, including COVID-19, are of great interest.
K. Willer, et. al. X-ray dark-field chest imaging for detection and quantification of emphysema in patients with chronic obstructive pulmonary disease: a diagnostic accuracy study. The Lancet Digital Health. November 1, 2021. doi: https://doi.org/10.1016/S2589-7500(21)00146-1
The International Hospital Federation (IHF) and Africa Healthcare Federation (AHF) have entered into a partnership to increase the participation of healthcare leaders from African countries in the IHF and other global hospital and healthcare initiatives.
Owlstone Medical, a global leader in breath biopsy for applications in early disease detection and precision medicine, closed its Series D financing round after securing $58 million in funding, exceeding its $50 million target after it was over subscribed. This brings the total raised by the company to more than $150 million since founding in […]
A ground-breaking regional anaesthesia device, invented by clinicians at The Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust (QEH) and developed in conjunction with medical device company Medovate, has been awarded ‘Patient Safety Innovation of the Year’ at this year’s HSJ Patient Safety Awards.
Brooks Automation and Cleveland Clinic have opened a new 22,000-square-foot biospecimen sample management and repository facility on Cleveland Clinic’s main campus in Cleveland, Ohio. The two-story biorepository is managed by Azenta Life Sciences, Brooks’ recently re-branded life sciences division, and includes ultra-cold and cryogenic storage. The new facility increases biobanking capacity at Cleveland Clinic and […]
Healthcare professionals create and update hundreds of thousands of patient notes, diagnostic reports, lab analyses, and other clinical records every day. Yet 80% of the data included in them is unstructured. Information about clinical diagnoses is reported using different expressions, terms, acronyms and even languages, making records impossible to consolidate, analyse and report on at […]
Hologic, a global leader in women’s health, will acquire Bolder Surgical, a privately held, U.S.-based company that provides advanced energy vessel sealing surgical devices, for approximately $160 million, subject to working capital and other customary closing adjustments.
New research published in Anaesthesia [1] says that the use of facemask ventilation during routine surgery should not be classed as an aerosol-generating procedure and does not increase the risk of COVID-19 transmission compared with normal breathing/coughing of patients.
Thus this procedure is not high risk and can be performed confidently for both routine surgery and emergency airway management. Its use should neither slow down operations or necessitate the use of extra personal protective equipment for medical teams.
Facemask ventilation is an essential intervention used by anaesthetists as part of the ‘life support’ of most anaesthetised patients having surgery. Its designation as an ‘aerosol-generating procedure’ (AGP) by the World Health Organization has had a major impact on operating theatre efficiency and processes. However, there is no direct evidence to indicate whether facemask ventilation is a high-risk procedure for aerosol generation. No study to date has measured the aerosol generated during facemask ventilation and the evidence for its AGP classification is based largely on one study of infections in anaesthetists dating back to the previous SARS-1 epidemic in 2003.
As a result of this AGP designation, current guidance dictates that anaesthetists performing facemask ventilation in a patient at risk of having COVID-19 would have to wear a respirator mask, eye protection and additional personal protective equipment. This would also apply to nearby theatre staff. In addition, extra time (up to half an hour per case) had to be added to each operation to allow sufficient air changes in theatre to remove any of the presumed infectious aerosol. This greatly reduces the number of cases that can be done each day, especially for urgent or emergency surgery, and is contributing to the backlog in the healthcare system.
In this new study, the authors conducted aerosol monitoring in anaesthetised patients during standard facemask ventilation, and facemask ventilation with an intentionally generated air leak – to mimic the worst-case scenario where aerosol might spread into the air. Recordings were made in ultraclean operating theatres (at Southmead Hospital, North Bristol NHS Trust, UK) and compared against the aerosol generated by each patient’s normal breathing and coughing.
Respiratory aerosol from normal breathing was reliably detected above the very low background particle concentrations with median aerosol concentration of 191 particles per litre. The average aerosol concentration detected during facemask ventilation without a leak (3 particles per litre) was 64-times less than that for breathing. When an intentional leak was introduced the aerosol count was 17 times lower than breathing (11 particles per litre).
When looking at peak particle concentrations the team found that a patient coughing produced a spike of 1260 particles per litre, compared to the peak of 60 per litre (20 times lower) for regular facemask ventilation and 120 per litre with an intentional leak introduced (10 times lower).
Dr Andrew Shrimpton, the lead author of the study, commented: “This study demonstrates that facemask ventilation, even when performed with an intentional leak, does not generate high levels of bioaerosol.”
The authors add: “The low concentration of aerosol detected during facemask ventilation even with an intentional leak is also reassuring given that this represents a worst-case scenario. Both normal breathing and a voluntary cough generate many-fold higher quantities of aerosol than facemask ventilation. On this basis, we believe facemask ventilation should not be considered an aerosol-generating procedure. Accumulating evidence demonstrates many procedures currently defined as aerosol-generating are not intrinsically high risk for generating aerosol, and that natural patient respiratory events often generate far higher amounts.”
They conclude: “The emerging evidence from quantitative clinical aerosol studies is yet to be incorporated into clinical guidance for aerosol-generating procedures and we believe this needs urgent reassessment. Declassification of some of these anaesthesia-related procedures as aerosol-generating would seem appropriate due to their lack of aerosol generation. Our findings also raise the broader question of whether the term ‘aerosol-generating procedure’ is still a useful concept for anaesthetic airway management practice in the prevention of SARS-CoV-2 or other airborne pathogens.”
Dr Mike Nathanson, President of the Association of Anaesthetists said: “This important work will allow clinicians to better understand the risks of general anaesthesia in patients with Covid. As we enter another winter, and with a high prevalence of Covid, the backlog of surgical cases is increasing. Anaesthetists will wish to carry on working for as many of their patients as possible. As the authors suggest, this research will inform the debate on how we can work safely.”
This study is the result of a collaboration between Anaesthetic and Aerosol research groups based in Bristol, UK and Melbourne, Australia as part of the NIHR funded AERATOR study. The results reinforce the findings of similar studies performed by the AERATOR group demonstrating many anaesthetic procedures are not high risk for aerosol generation.
[1] Quantitative evaluation of aerosol generation during manual facemask ventilation. A. J. Shrimpton, et al. Anaesthesia. 26 October 2021. doi: https://doi.org/10.1111/anae.15599
Most regulatory and quality professionals can think of a time when they struggled to find a specific requirement in the EU Medical Device Regulation (MDR). Finding all the instances where a particular compliance theme is mentioned can be painstaking and time-consuming. To allow easier navigation of the MDR, RQM+ has created a tool that allows users to search the legislation for specific subject areas.
The company’s internal specialists, as well as regulatory professionals within client companies, now save considerable administrative time every day by using the tool to consult the regulation. The tool enables quick searches by topic, chapter, article, and search term. Rather than highlighting or sticky noting a paper copy, users can save notes on company interpretations of MDR sections and even individual sentences in the tool itself.
The regulatory and quality consulting firm has already shared an IVDR filtering tool, to support manufacturers working towards the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). Both the IVDR and MDR tools are now freely available for medical device professionals to download and consult for their daily work.
Dr. Jaishankar Kutty, Vice President of Clinical Services at RQM+, said: “I was recently introduced to this tool after joining RQM+ this February, and my first reaction was: it would’ve been wonderful to have this tool when we waded into the initial MDR reviews at BSI! More than any other stakeholder, Notified Bodies need to know the regulation inside-out, and this tool makes it so easy to double check requirements. It’s now sitting on my desktop for easy access and it has been an extremely useful and welcome support so far.”
Nancy Morrison, Executive Director, Regulatory & Quality Consulting Services, initially developed these tools to support the RQM+ team. “We refer to regulation on a daily basis so we’re well aware of the frustrations of trying to find specific details or to gather all the sections referring to an area of compliance. We help our clients to put in place clear and organized processes to facilitate both short- and long-term compliance, and I hope that these tools will also make the work of regulatory professionals a little more straightforward.”
A demo of the RQM+ MDR Filtering Tool is available to watch here:
https://hubs.ly/H0XfKWW0
Download the RQM+ MDR Filtering Tool here:
https://hubs.ly/H0XfKWW0
Download the RQM+ IVDR Filtering Tool here:
https://hubs.ly/H0QNrQ_0
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