StarMed clinical evidence

Published studies on the StarMed range of CPAP and NIV respiratory hoods. For more information on the full StarMed range, including information sheets, videos and enquiries, please visit

Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study

Coppo, Anna et al. The Lancet Respiratory Medicine. 2020; Volume 8, Issue 8, 765-774

This prospective cohort study aimed to assess the feasibility and effect on gas exchange of prone positioning in 56 awake, non-intubated patients with COVID-19-related pneumonia. Several variables were evaluated including demographics, anthropometrics, arterial blood gas, and ventilation parameters. The primary measured outcome was the variation in oxygenation between baseline and resupination, which served as an index of pulmonary recruitment. Findings have shown that prone positioning in awake, spontaneously breathing patients is achievable outside of the critical care environment in the majority of the patients. Improvements have been observed in oxygenation via Helmet CPAP interface (n=44), reservoir mask (n=9) and Venturi mask (n=3), during prone position, which was preserved upon resupination by half of the patients for 1 hour or more, as well as non-significant reduction in dyspnoea. Furthermore, patient discomfort was minimal and prone position was found to be a valuable patient engaging technique that improved blood gas parameters in the short term in patients with COVID-19-related pneumonia.

Link to abstract

Helmet continuous positive airway pressure and prone positioning: A proposal for an early management of COVID-19 patients

Longhini F, Bruni A, Garofalo E, et al. Pulmonology. 2020;26(4):186-191

This study set out to investigate the safety and efficacy of combining helmet CPAP (hCPAP) and prone position in order to avoid deterioration of gas exchange and intubation in patients with COVID-19 induced pneumonia. Preliminary results from an ongoing study in COVID-19 patients, measuring tidal volume during hCPAP, showed a low mean tidal volume, high pulmonary compliance and low respiratory rate, which translates in a low transpulmonary pressure. At this stage the real effects and efficacy of hCPAP from the pathophysiological stand point is not known. In healthy patients, findings suggest that redistribution of perfusion could improve oxygenation in patients lacking hypoxic vasoconstriction. If the hypothesis presented in this study is confirmed, this may reduce the requirement for endotracheal intubation, invasive mechanical ventilation, hospital length of stay and improving the survival rates. Moreover, it could also reduce the need for ICU beds, which can be substituted by sub-intensive beds.

Link to abstract


Helmet-based noninvasive ventilation for acute exacerbation of chronic obstructive pulmonary disease: A case report

Park MH, Kim MJ, Kim AJ, Lee MJ, Kim JS. World J Clin Cases. 2020;8(10):1939-1943.

This report described a case of a 73-year-old man with COPD (stage 4) admitted to the ICU with complaints of cough, sputum, and dyspnoea. The patient was previously treated with oxygen at home for 10 months during the day time and oronasal mask-based NIV during night time. At the time of admission, the infection was detected and infiltration was also present. He was subsequently diagnosed with AECOPD by community-acquired pneumonia. Conditions deteriorated and invasive ventilation became unavoidable. However, helmet-based NIV was chosen as the patient refused to proceed with the invasive procedure. After three days of helmet NIV, he regained consciousness and hypercapnia recovered to pre-hospitalisation levels. This report demonstrates that helmet-based NIV may be a crucial treatment strategy used to treat patients with AECOPD that refuse invasive approaches and oronasal mask-based NIV is non-effective.

Link to abstract.

Protecting healthcare workers from SARS-CoV-2 infection: practical indications

Ferioli M, Cisternino C, Leo V, Pisani L, Palange P, Nava S. Eur Respir Rev. 2020 Apr 3;29(155):200068

The objective of this paper is to provide evidence-based recommendations for the correct use of respiratory devices in the COVID-19 emergency and protect healthcare workers from contracting the SARS-CoV-2 infection. Current evidence shows that around 20% of COVID-19 patients develop a severe Respiratory Distress Syndrome, which in almost a third of the cases requires respiratory support treatment. This type of support includes the use of oxygen therapy, HFNC, CPAP and NIV, which are non-invasive methods with a high risk of aerosol dispersion, especially in unprotected environments. Amongst those methods of delivery of non-invasive respiratory support, the use of a respiratory helmet with an inflatable neck cushion represents the safest option. In addition, data suggest that respecting the indications for the use of PPE is effective in preventing infections among healthcare workers, as demonstrated in a case–control study conducted during the SARS epidemic in Hong Kong. This study investigated the effective adhesion of personnel to PPE (gloves, disposable shirts, goggles and masks) and reported that none of the staff using all the safety measures contracted the virus, while all the infected staff had omitted at least one of them. Therefore, the helmet with neck cushion to treat infected patients with severe respiratory distress syndrome and PPE measures by the personnel must be adopted to prevent the spreading of infection amongst other patients and medical personnel.

Link to abstract.

Helmet CPAP to Treat Acute Hypoxemic Respiratory Failure in Patients with COVID-19: A Management Strategy Proposal

Radovanovic D, Rizzi M, Pini S, Saad M, Chiumello DA, Santus P. J Clin Med. 2020;9(4):1191

The author of this research study proposes a management strategy for the treatment of acute hypoxemic respiratory failure in patients with COVID-19. Respiratory support with NIV or high flow oxygen should be avoided to limit droplets/virus aerosolisation and healthcare worker contamination. Therefore, the implementation of CPAP through a helmet system may provide an effective and safer alternative to improve hypoxemia. In addition, the use of the helmet will also reduce room contamination and improve patient comfort, while guaranteeing better clinical assistance and long term tolerability. However, careful CPAP titration must be provided to better optimise the recruitment of unventilated lung sections to improve patient outcomes.