Abstract
Background Chest drain displacement is a common clinical problem that occurs 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 A 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 of 128, 3.9%; standard care displacement 13 of 129, 10.1%) but this was not statistically significant (OR for drain displacement 0.36, 95% CI 0.13–1.0, Chi-squared 1 degree of freedom (df)=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 0.08–0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59 of 131, 45.0%; standard care 18 of 132, 13.6%; Chi-squared 1 df=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.
Abstract
Results show that an intrapleural balloon is beneficial in preventing chest drain displacement, even when accounting for the use of chest drain sutures, but this was associated with minor difficulties with insertion and removal https://bit.ly/31fm7fB
Footnotes
This article has an editorial commentary: https://doi.org/10.1183/13993003.00434-2022This article has supplementary material available from erj.ersjournals.com
This trial was prospectively registered as ISRCTN37304337. No individual participant data will be available. The study protocol and statistical analysis plan will be available.
Author contributions: S.V. Kemp, N.M. Rahman and R.M. Mercer conceived and designed the study. R.M. Mercer and E. Hedley prepared the ethics protocol. R.M. Mercer, E. Mishra, R. Banka, J.P. Corcoran, C. Daneshvar, R.K. Panchal, T. Saba, M. Caswell, S. Johnstone, D. Menzies, S. Ahmer, M. Shahidi, N.A. Maskell, M. Gautam, G. Cox, C. Orton, J. Lyons, N. Maddekar, D. De Fonseka, K. Prior, S. Gerry, G. Robinson, L. Brown, M. Munavvar, R.J. Hallifax, A.O. Clive, S. Barnes, N.M. Rahman and S.V. Kemp were involved in recruitment and data collection. R.M. Mercer, R.J. Hallifax, S. Gerry and N.M. Rahman analysed the data and performed statistical analyses. S.V. Kemp, R.F. Miller, K.G. Blyth, P.L. Shah and N.M. Rahman provided materials and expert knowledge. S.V. Kemp, R.F. Miller and N.M. Rahman supervised the study. R.M. Mercer and N.M. Rahman wrote the first draft of the manuscript. All authors revised and approved the final version of the manuscript. R.M. Mercer, N.M. Rahman and S.V. Kemp are guarantors of the manuscript.
Conflict of interest: N.M. Rahman receives consultancy fees from Rocket Medical UK. None of the other authors report any conflict of interests relevant to the production of this article. Rocket Medical UK provided funding to conduct the study, and clinical materials to conduct the study, but had no role in design, conduct, analysis or publication of the manuscript. R.M. Mercer received funding from the Royal Brompton and Harefield Charitable Trust. All other authors disclose no potential conflicts of interest.
- Received June 21, 2021.
- Accepted November 23, 2021.
- Copyright ©The authors 2022. For reproduction rights and permissions contact permissions{at}ersnet.org
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