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

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.

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.

Noninvasive Positive-Pressure Ventilation With Different Interfaces in Patients With Respiratory Failure After Abdominal Surgery: a Matched-Control Study

Conti G, Cavaliere F, Costa R, Craba A, Catarci S, Festa V, Proietti R, Antonelli M. Respir Care. 2007 Nov;52(11):1463-71

Comparison of the efficacy of NPPV delivered to 25 patients via helmet, matched with 25 controls chosen from historical patients treated with face mask. Authors conclude that NPPV by helmet can be 'an alternative to conventional ventilation'.

Link to abstract.

Noninvasive Positive Pressure Ventilation Using a Helmet in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Feasibility Study

Antonelli M, Pennisi MA, Pelosi P, Gregoretti C, Squadrone V, Rocco M, Cecchini L, Chiumello D, Severgnini P, Proietti R, Navalesi P, Conti G. Anesthesiology. 2004 Jan;100(1):16-24

Study of 33 patients with COPD treated with helmet NPPV, compared with 33 historical controls treated with face mask NPPV. In the helmet group, no patients were unable to tolerate NPPV, whereas five of the control group required intubation. Authors conclude that helmet NPPV 'can be used to treat chronic COPD with acute exacerbation'.

Link to abstract.