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Pleural disease
Randomised Ambulatory Management of Primary Pneumothorax (RAMPP): protocol of an open-label, randomised controlled trial
  1. Rob Hallifax1,2,
  2. Magda Laskawiec-Szkonter2,
  3. Melissa Dobson2,
  4. Stephen Gerry3,
  5. Robert F Miller4,
  6. John E Harvey5 and
  7. Najib Rahman1,6
  1. 1Department of Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  2. 2Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK
  3. 3Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  4. 4Institute for Global Health, University College London Institute of Epidemiology and Health Care, London, UK
  5. 5Department of Respiratory Medicine, North Bristol NHS Trust, Bristol, UK
  6. 6NIHR Biomedical Research Centre Oxford, University of Oxford, Oxford, UK
  1. Correspondence to Dr Rob Hallifax; robhallifax{at}yahoo.com

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).

Trial registration number ISRCTN79151659

  • pleural disease
  • pneumothorax
  • ambulatory
  • outpatient

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/.

https://doi.org/10.1136/bmjresp-2019-000403

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    Footnotes

    • Contributors The protocol was drafted by RH, ML-S and NR. The final protocol and manuscript were reviewed and approved by all authors.

    • Funding This work was funded by NIHR Research for Patient Benefit (grant number PB-PG-0213-30098). The ambulatory devices (Pleural Vent) and consumables were supplied by Rocket Medical (UK). The digital suction devices (Thopaz+) and consumables were supplied by Medela (Switzerland).

    • Competing interests NR has received consultancy fees from Rocket Medical. All other authors have no competing interests to declare.

    • Patient consent for publication Not required.

    • Ethics approval The trial is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.

    • Provenance and peer review Not commissioned; externally peer reviewed.