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

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.

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.

Prophylactic use of helmet CPAP after pulmonary lobectomy: a prospective randomized controlled study

Barbagallo M, Ortu A, Spadini E, Salvadori A, Ampollini L, Internullo E, Ziegler S, Fanelli G. Respir Care. 2012 Sep;57(9):1418-24

Randomised trial of 50 patients allocated to receive either continuous oxygen therapy or two cycles of helmet CPAP for 120 minutes. Results suggest that by the end of the second helmet treatment, patient's had a significantly higher PaO2/FiO2 but the improvement in oxygenation was not lasting. However, helmet CPAP was 'secure and well tolerated'.

Link to abstract.

Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlled trial

Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P.
Chest. 2010 Jul;138(1):114-20

Multi-centre, randomised controlled trial. 47 patients admitted to ED with moderate hypoxemic acute respiratory failure (ARF) due to community-acquired pneumonia (CAP) were split into helmet CPAP or standard oxygen therapy groups. Primary end point was time to reach PaO2/FiO2 ratio > 315. The proportion of patients who reached the primary end point was also recorded. Authors conclude that CPAP delivered by helmet rapidly improves oxygenation in this scenario.

Link to abstract.