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

Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study

Coppo, Anna et al. The Lancet Respiratory Medicine. 2020; Volume 8, Issue 8, 765-774

This prospective cohort study aimed to assess the feasibility and effect on gas exchange of prone positioning in 56 awake, non-intubated patients with COVID-19-related pneumonia. Several variables were evaluated including demographics, anthropometrics, arterial blood gas, and ventilation parameters. The primary measured outcome was the variation in oxygenation between baseline and resupination, which served as an index of pulmonary recruitment. Findings have shown that prone positioning in awake, spontaneously breathing patients is achievable outside of the critical care environment in the majority of the patients. Improvements have been observed in oxygenation via Helmet CPAP interface (n=44), reservoir mask (n=9) and Venturi mask (n=3), during prone position, which was preserved upon resupination by half of the patients for 1 hour or more, as well as non-significant reduction in dyspnoea. Furthermore, patient discomfort was minimal and prone position was found to be a valuable patient engaging technique that improved blood gas parameters in the short term in patients with COVID-19-related pneumonia.

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Helmet continuous positive airway pressure and prone positioning: A proposal for an early management of COVID-19 patients

Longhini F, Bruni A, Garofalo E, et al. Pulmonology. 2020;26(4):186-191

This study set out to investigate the safety and efficacy of combining helmet CPAP (hCPAP) and prone position in order to avoid deterioration of gas exchange and intubation in patients with COVID-19 induced pneumonia. Preliminary results from an ongoing study in COVID-19 patients, measuring tidal volume during hCPAP, showed a low mean tidal volume, high pulmonary compliance and low respiratory rate, which translates in a low transpulmonary pressure. At this stage the real effects and efficacy of hCPAP from the pathophysiological stand point is not known. In healthy patients, findings suggest that redistribution of perfusion could improve oxygenation in patients lacking hypoxic vasoconstriction. If the hypothesis presented in this study is confirmed, this may reduce the requirement for endotracheal intubation, invasive mechanical ventilation, hospital length of stay and improving the survival rates. Moreover, it could also reduce the need for ICU beds, which can be substituted by sub-intensive beds.

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Non-invasive ventilation in prone position for refractory hypoxemia after bilateral lung transplantation

Feltracco P, Serra E, Barbieri S, Persona P, Rea F, Loy M, Ori C. Clin Transplant. 2009 Sep-Oct;23(5):748-50.

This case report described the clinical course of two patients that suffered from refractory hypoxemia caused by the post-reimplantation syndrome treated with NIV in the prone and Trendelenburg positions. The first case report was characterised by a 37-year old woman undergoing bilateral sequential single lung transplant (BSSLT), as a consequence of end stage respiratory failure. She was extubated a few hours after arriving to the ICU and subsequently developed extensive patchy alveolar consolidations in the dorsal and basal regions of the lungs. Due to unresponsive hypoxia, despite the treatment with high oxygen using a face mask, the patient was treated with NIV through respiratory helmet. This approach in conjunction with alternating between the prone and the Trendelenburg positions, improved the patient's condition. Moreover, the implanted lungs were better filled with air and further improvements of oxygenation allowed the removal of the helmet. In the second case, a 44-year-old man with cystic fibrosis underwent BSSLT due to end-stage respiratory failure. Several hours after arriving in the ICU the patient was extubated, but due to increased oxygen desaturation he was treated with facemask delivered NIV. His gas exchange deteriorated as a consequence of lung infiltrations and atelectasis of the lower lobes. Similar to the first case, the implementation of the mask NIV delivery and change in position lead to the improvement of the patient's condition. Therefore, the results from these two case studies show that the use of helmet or facemask NIV in conjunction with position changes represents a valuable approach in patients that have undergone lung transplantation.

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Helmet-based noninvasive ventilation for acute exacerbation of chronic obstructive pulmonary disease: A case report

Park MH, Kim MJ, Kim AJ, Lee MJ, Kim JS. World J Clin Cases. 2020;8(10):1939-1943.

This report described a case of a 73-year-old man with COPD (stage 4) admitted to the ICU with complaints of cough, sputum, and dyspnoea. The patient was previously treated with oxygen at home for 10 months during the day time and oronasal mask-based NIV during night time. At the time of admission, the infection was detected and infiltration was also present. He was subsequently diagnosed with AECOPD by community-acquired pneumonia. Conditions deteriorated and invasive ventilation became unavoidable. However, helmet-based NIV was chosen as the patient refused to proceed with the invasive procedure. After three days of helmet NIV, he regained consciousness and hypercapnia recovered to pre-hospitalisation levels. This report demonstrates that helmet-based NIV may be a crucial treatment strategy used to treat patients with AECOPD that refuse invasive approaches and oronasal mask-based NIV is non-effective.

Link to abstract.

Neurally-Adjusted Ventilatory Assist for Noninvasive Ventilation via a Helmet in Subjects With COPD Exacerbation: A Physiologic Study

Longhini F, Liu L, Pan C, et al. Respir Care. 2019;64(5):582-589

In this study compared neurally-controlled pressure support through a helmet with pressure support through a face mask for subject comfort, breathing pattern, gas exchange, pressurization and triggering performance, and patient-ventilator synchrony. Two 30-min trials of NIV were randomly delivered to 10 subjects with COPD exacerbation. The first group was treated with pressure support through a face mask and the second group with NAVA through a helmet. Several parameters were evaluated including subject comfort, breathing frequency, respiratory drive, arterial blood gases, pressure-time product (PTP) of the first 300 ms and 500ms after initiation of subject effort, inspiratory trigger delay, and rate of asynchrony determined as the asynchrony index. NAVA through a helmet significantly improved comfort compared with pressure support through a face mask. Although the breathing pattern was not different between the methods, the respiratory drive was slightly reduced during NAVA through a helmet in comparison with pressure support through a face mask. Gas exchange was also not different between the trials. The PTP was comparable between trials, whereas triggering performance, patient-ventilator interaction, and synchrony were all improved by NAVA through a helmet compared with pressure support through a face mask. Therefore, in subjects with COPD with exacerbation, NAVA through a helmet improved comfort, triggering performance, and patient-ventilator synchrony compared with pressure support through a face mask.

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