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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37304337
Enrollment
267
Registered
2018-01-11
Start date
2018-02-15
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intercostal drain Respiratory

Interventions

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 Thora

Sponsors

Royal Brompton & Harefield NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or over 2. Able to give written informed consent 3. Requiring intercostal tube drainage for clinical reasons

Exclusion criteria

Exclusion criteria: 1. Inability to provide written informed consent 2. Requiring a large bore drain according to local PI or delegated person’s clinical judgement 3. Frank haemothorax (requiring a large bore chest drain in view of the local PI or delegated person) 4. Pleural space (known prior to intervention) to be too small to place either standard or interventional drain according to local PI or delegated person 5. Drain planned to be in situ for less than 24 hours 6. Any contraindication to chest drain insertion (such as uncorrected clotting abnormality) 7. Any patient in acute pain or with an emergency presentation where consideration of the study would inappropriately delay patient care

Design outcomes

Primary

MeasureTime frame
Unintentional/accidental chest drain displacement rate (UACDR); Timepoint(s): Within 30 days

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026