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