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

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.

New versus Conventional Helmet for Delivering Noninvasive Ventilation: A Physiologic, Crossover Randomized Study in Critically Ill Patients.

Olivieri C, Longhini F, Cena T, Cammarota G, Vaschetto R, Messina A, Berni P, Magnani C, Della Corte F, Navalesi P. Anesthesiology. 2016 Jan;124(1):101-8

This study set out to assess the efficacy and safety of the new helmet (NH) in comparison to the standard helmet (SH) for the prevention of post-extubation respiratory failure (PERF). Both devices were also compared with the endotracheal tube (ETT) in place before extubation. Each of the 14 patients underwent three 30 minutes trials in pressure support ventilation, starting with ETT and after extubation, with a SH (Castar R, Intersurgical) and NH in a random order. Several parameters were evaluated including comfort, triggering delays, rates of pressurization, respiratory drive and frequency, arterial blood gases (ABGs) and rate of asynchrony. Findings have shown that the use of NH improved comfort, inspiratory trigger delay, pressurization and patient’s inspiratory time. On the other hand, respiratory drive and frequency, ABGs and rate of asynchrony were comparable between the two devices. Moreover, ETT outperformed both devices in all the parameters, apart from respiratory rate and asynchronies. Therefore, the NH provided a superior comfort and better patient-ventilator interaction in comparison to the SH.

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.