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Randomised ambulatory management of primary pneumothorax (RAMPP): Protocol of an open-label, randomised controlled trial

Hallifax, R; Laskawiec-Szkonter, M; Dobson, M; Gerry, S; Miller, RF; Harvey, JE; Rahman, N; (2019) Randomised ambulatory management of primary pneumothorax (RAMPP): Protocol of an open-label, randomised controlled trial. BMJ Open Respiratory Research , 6 (1) , Article e000403. 10.1136/bmjresp-2019-000403. Green open access

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Abstract

Introduction Pneumothorax is a common clinical problem. Primary spontaneous pneumothorax (PSP) occurs in otherwise fit young patients, but optimal management is not clearly defined and often results in a long hospital stay. Ambulatory treatment options are available, but the existing data on their efficacy are poor. The Randomised Ambulatory Management of Primary Pneumothorax trial is a multicentre, randomised controlled trial comparing ambulatory management with standard care, specifically designed to safely and effectively reduce hospital stay. Methods and analysis 236 patients with PSP will be recruited from UK hospitals. Patients will be randomised 1:1 to treatment to either the 'Intervention' arm (ambulatory device; Rocket Pleural Vent) or the 'Control' arm (aspiration ± standard chest drain insertion). Patients will be followed up for a total of 12 months to assess recurrence rates. The primary outcome is total length of stay in hospital (including readmissions) up to 30 days postrandomisation. The secondary outcomes are pain and breathlessness scores, air leak measurement and radiological evidence (on CT scanning) of emphysema-like changes, compared with short-term and long-term outcomes, respectively, and health economic analysis. Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service Committee South-Central Oxford A (15/SC/0240).

Type: Article
Title: Randomised ambulatory management of primary pneumothorax (RAMPP): Protocol of an open-label, randomised controlled trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bmjresp-2019-000403
Publisher version: https://doi.org/:10.1136/ bmjresp-2019-000403
Language: English
Additional information: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/10073709
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