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.

Helmet CPAP versus Oxygen Therapy in Hypoxemic Acute Respiratory Failure: A Meta-Analysis of Randomized Controlled Trials

Yuwen Luo, Yan Luo, Yun Li, Luqian Zhou, Zhe Zhu, Yitai Chen, Yuxia Huang, and Xin Chen. Yonsei Med J. 2016 Jul 1; 57(4): 936–941.

This meta-analysis aimed to investigate the effects of helmet CPAP on gas exchange, mortality, intubation rate and in-hospital mortality rate in comparison with the conventional oxygen therapy (COT). Data obtained from four studies and 377 subjects with hypoxemic acute respiratory failure (hARF) showed that helmet CPAP significantly increased the PaO2/FiO2, and reduced the arterial carbon dioxide levels, intubation rate and in-hospital mortality rates as compared to COT therapy. These results suggest that the helmet improves oxygenation, reduces mortality and intubation rates. However, large randomised controlled trials are needed to validate these findings.

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.

Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia

Brambilla AM, Aliberti S, Prina E, Nicoli F, Forno MD, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Intensive Care Med. 2014 Jul;40(7):942-9

Multi-centre, randomised controlled trial across four Italian centres. Patients split into helmet CPAP and Venturi mask groups. Primary end point was percentage of patients meeting criteria for ETI. Authors conclude helmet CPAP reduces the risk of meeting ETI criteria in this scenario.

Link to abstract.