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 https://www.intersurgical.com/info/starmed

New Setting of Neurally Adjusted Ventilatory Assist during Noninvasive Ventilation through a Helmet [CaStar R Next]

Cammarota G, Longhini F, Perucca R, Ronco C, Colombo D, Messina A, Vaschetto R, Navalesi P.
Anesthesiology. 2016 Dec;125(6):1181-1189

Randomised trial of 15 patients undergoing three 30-minutes ventilation trials using two different helmets. The ventiltion modes were randomly applied: pneumatically triggered pressure support ventilation (PSP), neurally adjusted ventilatory assist (NAVA) and neurally controlled pressure support (PSN). The latter is a new proposed setting of the NAVA mode. Authors conclude that PSN improves comfort and patient-ventilator interactions in this scenario.

Link to abstract.

Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. JAMA. 2016 Jun 14;315(22):2435-41

Single-centre randomised trial of 83 patients to determine whether NIV through helmet improves intubation rate among patients with ARDS. Primary outcome was proportion of patients who needed ETI, secondary outcomes included 28-day invasive ventilator-free days, ICU length of stay, and 90-day mortality. Authors conclude helmet NIV treatment resulted in a significant reduction of intubation rates as well as statistically significant reduction in 90-day mortality.

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.

Non-invasive ventilation delivered by conventional interfaces and helmet in the emergency department

Pelosi P, Severgnini P, Aspesi M, Gamberoni C, Chiumello D, Fachinetti C, Introzzi L, Antonelli M, Chiaranda M. Eur J Emerg Med. 2003 Jun;10(2):79-86.

Early review of the use of NIV and the helmet interface in the emergency department and in the pre-hospital setting. Authors concluded that the helmet 'can extend the application of non-invasive positive pressure ventilation in different categories of patients with respiratory failure'.

Link to abstract.