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A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement

Rachel M Mercer, Eleanor Mishra, Radhika Banka, John P Corcoran, Cyrus Daneshvar, Rakesh K Panchal, Tarek Saba, Melanie Caswell, Sarah Johnstone, Daniel Menzies, Sana Ahmer, Mitra Shahidi, Amelia O Clive, Manish Gautam, Giles Cox, Chris Orton, Judith Lyons, Nadeem Maddekar, Duneesha De Fonseka, Kathryn Prior, Simon Barnes, Grace Robinson, Louise Brown, Mohammed Munavvar, Palav L Shah, Robert J Hallifax, Kevin G Blyth, Emma Hedley, Nick A Maskell, Stephen Gerry, Robert F Miller, Najib M Rahman, Samuel V Kemp
European Respiratory Journal 2021; DOI: 10.1183/13993003.01753-2021
Rachel M Mercer
1University of Oxford Respiratory Trials Unit, Churchill Hospital, Oxford, UK
2Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford, UK
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Eleanor Mishra
3Department of Respiratory Medicine, Norfolk and Norwich University Hospitals, Norwich, UK
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Radhika Banka
2Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford, UK
3Department of Respiratory Medicine, Norfolk and Norwich University Hospitals, Norwich, UK
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John P Corcoran
4University Hospitals Plymouth NHS Trust, Plymouth, UK
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Cyrus Daneshvar
4University Hospitals Plymouth NHS Trust, Plymouth, UK
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Rakesh K Panchal
5Institute for Lung Health, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK
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Tarek Saba
6Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK
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Melanie Caswell
6Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK
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Sarah Johnstone
5Institute for Lung Health, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK
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Daniel Menzies
7Glan Clwyd Hospital, North Wales, UK
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Sana Ahmer
7Glan Clwyd Hospital, North Wales, UK
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Mitra Shahidi
8Buckinghamshire Healthcare NHS Trust, Amersham, UK
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Amelia O Clive
9Academic Respiratory Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, UK
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Manish Gautam
10Department of Respiratory Medicine, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK
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Giles Cox
11King's Mill Hospital, Mansfield, UK
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Chris Orton
12Royal Brompton Hospital, London, UK
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Judith Lyons
13North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK
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Nadeem Maddekar
14University Hospitals of North Midlands, Stoke-on-Trent, UK
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Duneesha De Fonseka
15Department of Respiratory Medicine, Sheffield Teaching Hospitals, Sheffield, UK
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Kathryn Prior
16University Hospitals Morecambe Bay, Kendal, UK
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Simon Barnes
17Somerset Lung Centre, Musgrove Park Hospital, Taunton, UK
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Grace Robinson
18Royal Berkshire NHS Foundation Trust, Reading, UK
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Louise Brown
19North Manchester General Hospital, Manchester, UK
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Mohammed Munavvar
20Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK
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Palav L Shah
12Royal Brompton Hospital, London, UK
21National Heart and Lung Institute, Imperial College, London, UK
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Robert J Hallifax
1University of Oxford Respiratory Trials Unit, Churchill Hospital, Oxford, UK
2Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford, UK
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Kevin G Blyth
22Queen Elizabeth University Hospital, Glasgow/Institute of Cancer Sciences, University of Glasgow, Glasgow, UK
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Emma Hedley
1University of Oxford Respiratory Trials Unit, Churchill Hospital, Oxford, UK
2Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford, UK
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Nick A Maskell
9Academic Respiratory Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, UK
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Stephen Gerry
23Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Robert F Miller
24Institute for Global Health, University College London, London, UK
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Najib M Rahman
1University of Oxford Respiratory Trials Unit, Churchill Hospital, Oxford, UK
2Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford, UK
25NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
26NMR and SVK contributed jointly
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  • For correspondence: najib.rahman@ndm.ox.ac.uk
Samuel V Kemp
12Royal Brompton Hospital, London, UK
21National Heart and Lung Institute, Imperial College, London, UK
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Abstract

Background Chest drain displacement is a common clinical problem, occurring in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.

Methods Prospective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively-defined unintentional or accidental chest drain displacement.

Results 267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5/128, 3.9%; standard care displacement 13/129, 10.1%) but this was not statistically significant (Odds Ratio (OR) for drain displacement 0.36, 95% CI 0.13 to 1.0, χ2 1df=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall out rate (adjusted OR 0.27, 95% CI 0.08 to 0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59/131, 45.0%; standard care 18/132, 13.6%; χ2 1df=31.3, p<0.0001).

Conclusion Balloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

Conflict of interest: Dr. Mercer has nothing to disclose.

Conflict of interest: Dr. Mishra has nothing to disclose.

Conflict of interest: Dr. Banka has nothing to disclose.

Conflict of interest: Dr. Corcoran has nothing to disclose.

Conflict of interest: Dr. Daneshvar has nothing to disclose.

Conflict of interest: Dr. Panchal has nothing to disclose.

Conflict of interest: Dr. Saba has nothing to disclose.

Conflict of interest: Mrs Caswell has nothing to disclose.

Conflict of interest: Mrs Johnstone has nothing to disclose.

Conflict of interest: Dr. Menzies has nothing to disclose.

Conflict of interest: Dr. Ahmer has nothing to disclose.

Conflict of interest: Dr. Shahidi has nothing to disclose.

Conflict of interest: Dr. Clive has nothing to disclose.

Conflict of interest: Dr. Gautam has nothing to disclose.

Conflict of interest: Dr. Cox has nothing to disclose.

Conflict of interest: Dr. Orton has nothing to disclose.

Conflict of interest: Dr. Lyons has nothing to disclose.

Conflict of interest: Dr. Maddekar has nothing to disclose.

Conflict of interest: Dr. Defonseka has nothing to disclose.

Conflict of interest: Dr. Prior has nothing to disclose.

Conflict of interest: Dr. Barnes has nothing to disclose.

Conflict of interest: Dr. Robinson has nothing to disclose.

Conflict of interest: Dr. Brown has nothing to disclose.

Conflict of interest: Dr. Munavvar has nothing to disclose.

Conflict of interest: Dr. Shah has nothing to disclose.

Conflict of interest: Dr. Hallifax has nothing to disclose.

Conflict of interest: Dr. Blyth has nothing to disclose.

Conflict of interest: Mrs. Hedley has nothing to disclose.

Conflict of interest: Dr. Maskell has nothing to disclose.

Conflict of interest: Dr. Gerry has nothing to disclose.

Conflict of interest: Dr. Maskell has nothing to disclose.

Conflict of interest: Dr. Rahman reports personal fees from Rocket Medical, outside the submitted work;.

Conflict of interest: Dr. Kemp has nothing to disclose.

  • Received June 21, 2021.
  • Accepted November 23, 2021.
  • Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org
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A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement
Rachel M Mercer, Eleanor Mishra, Radhika Banka, John P Corcoran, Cyrus Daneshvar, Rakesh K Panchal, Tarek Saba, Melanie Caswell, Sarah Johnstone, Daniel Menzies, Sana Ahmer, Mitra Shahidi, Amelia O Clive, Manish Gautam, Giles Cox, Chris Orton, Judith Lyons, Nadeem Maddekar, Duneesha De Fonseka, Kathryn Prior, Simon Barnes, Grace Robinson, Louise Brown, Mohammed Munavvar, Palav L Shah, Robert J Hallifax, Kevin G Blyth, Emma Hedley, Nick A Maskell, Stephen Gerry, Robert F Miller, Najib M Rahman, Samuel V Kemp
European Respiratory Journal Jan 2021, 2101753; DOI: 10.1183/13993003.01753-2021

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A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement
Rachel M Mercer, Eleanor Mishra, Radhika Banka, John P Corcoran, Cyrus Daneshvar, Rakesh K Panchal, Tarek Saba, Melanie Caswell, Sarah Johnstone, Daniel Menzies, Sana Ahmer, Mitra Shahidi, Amelia O Clive, Manish Gautam, Giles Cox, Chris Orton, Judith Lyons, Nadeem Maddekar, Duneesha De Fonseka, Kathryn Prior, Simon Barnes, Grace Robinson, Louise Brown, Mohammed Munavvar, Palav L Shah, Robert J Hallifax, Kevin G Blyth, Emma Hedley, Nick A Maskell, Stephen Gerry, Robert F Miller, Najib M Rahman, Samuel V Kemp
European Respiratory Journal Jan 2021, 2101753; DOI: 10.1183/13993003.01753-2021
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