A randomised controlled trial of the use of a dedicated ballooned intercostal drain

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Randomisation will be via an online platform and will be 1:1, minimised by site and underlying aetiology. The standard arm will be insertion of a conventional chest drain as per standard British Thoracic Society Guidelines. The Interventional arm will have a chest drain with a balloon on the shaft which will be inflated once in the pleural cavity. Both arms will be monitored for unintentional drain displacement, timing of drain removal, pain and any complications. The time that the drain is in situ is variable but is usually under 1 week. All patients will be followed up at 30 days after drain removal. CONDITION: Specialty: Respiratory disorders, Primary sub‐specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of pleura ; Respiratory PRIMARY OUTCOME: Unintentional/accidental chest drain displacement rate (UACDR); Timepoint(s): Within 30 days SECONDARY OUTCOME: 1. Pain, measured using the visual analogue scale (VAS) at baseline then twice daily for the first 5 days or until the drain has been removed, whichever is sooner; 2. Complications listed on the CRFs and to be recorded daily on the CRFs; 3. Length of stay, further pleural procedures, number of days any chest drain in situ, number of radiological investigations, consequences of drain displacement, documented on CRFs up to 30 days after drain removal INCLUSION CRITERIA: 1. Age 18 years or over 2. Able to give written informed consent 3. Requiring intercostal tube drainage for clinical reasons
Epistemonikos ID: df8537a29c55c6c9fb8604a7bbb8913e3670c25f
First added on: Aug 24, 2024