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

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


Non-invasive ventilation in prone position for refractory hypoxemia after bilateral lung transplantation

Feltracco P, Serra E, Barbieri S, Persona P, Rea F, Loy M, Ori C. Clin Transplant. 2009 Sep-Oct;23(5):748-50.

This case report described the clinical course of two patients that suffered from refractory hypoxemia caused by the post-reimplantation syndrome treated with NIV in the prone and Trendelenburg positions. The first case report was characterised by a 37-year old woman undergoing bilateral sequential single lung transplant (BSSLT), as a consequence of end stage respiratory failure. She was extubated a few hours after arriving to the ICU and subsequently developed extensive patchy alveolar consolidations in the dorsal and basal regions of the lungs. Due to unresponsive hypoxia, despite the treatment with high oxygen using a face mask, the patient was treated with NIV through respiratory helmet. This approach in conjunction with alternating between the prone and the Trendelenburg positions, improved the patient's condition. Moreover, the implanted lungs were better filled with air and further improvements of oxygenation allowed the removal of the helmet. In the second case, a 44-year-old man with cystic fibrosis underwent BSSLT due to end-stage respiratory failure. Several hours after arriving in the ICU the patient was extubated, but due to increased oxygen desaturation he was treated with facemask delivered NIV. His gas exchange deteriorated as a consequence of lung infiltrations and atelectasis of the lower lobes. Similar to the first case, the implementation of the mask NIV delivery and change in position lead to the improvement of the patient's condition. Therefore, the results from these two case studies show that the use of helmet or facemask NIV in conjunction with position changes represents a valuable approach in patients that have undergone lung transplantation.

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.

Noninvasive ventilation with helmet versus control strategy in patients with acute respiratory failure: a systematic review and meta-analysis of controlled studies

Qi Liu, Yonghua Gao, Rongchang Chen and Zhe Cheng. Crit Care. 2016;20(1):265

This meta-analysis aimed to analyse the effects of NIV using the helmet in comparison to a control strategy in patients with acute respiratory failure (ARF). Primary outcomes were hospital mortality, intubation rate and complications and secondary outcomes included length of intensive care unit (ICU) stay, gas exchange and respiratory rate. Results from 11 studies and 621 patients demonstrated that the overall mortality was circa 18% in the helmet NIV group versus circa 31% in the in the control group. The helmet implementation was also linked with lower hospital mortality, intubation and complication rates. Furthermore, subgroup analysis showed that the helmet reduced mortality mainly in hypoxemic ARF patients and the PaCO2 was influenced by the type of ARF and ventilation mode. Thus, the helmet represents a superior approach to the conventional therapy, but additional larger studies must be carried out to confirm these results.

Link to abstract.

Early CPAP prevents evolution of acute lung injury in patients with hematologic malignancy

Squadrone V, Massaia M, Bruno B, Marmont F, Falda M, Bagna C, Bertone S, Filippini C, Slutsky AS, Vitolo U, Boccadoro M, Ranieri VM. Intensive Care Med. 2010 Oct; 36(10):1666-74

Study to determine effectiveness of early CPAP delivered in the ward to prevent occurrence of ALI requiring intensive care admission for mechanical ventilation. Primary outcomes measured were need of mechanical ventilation and intubation rate among patients requiring ICU admission.  Authors conclude early CPAP in this scenario prevents 'evolution to acute lung injury'.

Link to abstract.