Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020, 164(2):213-215 | DOI: 10.5507/bp.2020.008

Efficacy and analgesic use during the therapy of iatrogenic pneumothorax using Pleuralvent™ and Chest Tube (ASPIRATE): A randomised controlled trial protocol

Milan Sovaa, Martin Porubab, Samuel Genzora, Petr Jakubeca, Jaromir Zatloukala, Vitezslav Koleka, Karel Urbanekb, Martina Vasakovac, Ludek Stehlikc, Pavla Zackovac, Amjad Ghazal Asswadd
a Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic
b Department of Pharmacology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic
c Department of Respiratory Medicine, 1st Faculty of Medicine Charles University in Prague, Thomayer Hospital Prague, Czech Republic
d Emergency Department, West Middlesex University Hospital, London, United Kingdom of Great Britain and Northern Ireland

Background: Iatrogenic pneumothorax is a common complication of various diagnostic and therapeutic procedures such as transbronchial lung biopsies. The classical mode of treatment is chest tube insertion. Pneumothorax devices are now available on the market but there is a dearth of data on their efficacy to treat iatrogenic pneumothorax. It is important to provide such data as the pathophysiology of iatrogenic pneumothorax is different in comparison with spontaneous pneumothorax for which some data is available.

Methods: This is a randomized, non-blinded, actively controlled trial of effectivity of iatrogenic pneumothorax treatment using the Pleuralvent™ device and chest tube insertion (16F). The secondary aim is to compare the overall pain level and the need for analgesic treatment in both treatment arms. We are planning to enrol 126 patients (63 in each treatment arm).

Discussion: Preliminary results showed similar effectivity of the Pleuralvent™ system compared to large bore chest tube insertion. This randomized clinical trial should confirm these results and prove that the Pleuralvent™ system is an effective way of treatment of patients with iatrogenic pneumothorax. If Pleuralvent™ proves to have the same level of efficacy, it may become the standard of care of patients with iatrogenic pneumothorax. Trial registration: ClinicalTrials.gov Identifier: NCT03700554

Keywords: iatrogenic pneumothorax, Pleuralvent™, chest tube

Received: May 28, 2019; Revised: May 28, 2019; Accepted: February 27, 2020; Prepublished online: March 9, 2020; Published: June 18, 2020  Show citation

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Sova, M., Poruba, M., Genzor, S., Jakubec, P., Zatloukal, J., Kolek, V., ... Asswad, A.G. (2020). Efficacy and analgesic use during the therapy of iatrogenic pneumothorax using Pleuralvent™ and Chest Tube (ASPIRATE): A randomised controlled trial protocol. Biomedical papers, 164(2), 213-215. doi: 10.5507/bp.2020.008
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