Randomised trial comparing the use of suction with underwater seal versus only an underwater seal applied to chest drains following lung resection
| ISRCTN | ISRCTN20243318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20243318 |
| Protocol serial number | N0013145914 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK), Own Account |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Nelson Alphonso
Scientific
Scientific
Cardiothoracic Surgery
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE17EH
United Kingdom
| Phone | +44 (0)20 7188 7188 |
|---|---|
| nelson.a@bigfoot.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is there a difference between the two groups with respect to the three primary outcomes? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Lobectomy |
| Intervention | Chest drains connected to an underwater seal are routinely left in the chest cavity (pleural space) following lung resections. They provide a one way escape route for any air that might leak from the surface of the lung and for any fluid that might collect in the chest cavity. This helps to maintain a negative pressure in the pleural cavity and facilitates lung expansion. We propose to compare the duration of air leak following lung resection between two groups of prospectively randomised patients one of which will have suction applied to the underwater seal. We will record the time to the last air leak and then determine any statistically significant difference (if any) between the two groups. Randomisation will be into two groups: 1. chest drain connected to water seal only 2. chest drain connected to water seal and wall suction applied to the water seal at 3 kPa. Suction started in the recovery room immediately after the operation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Time to last bubble (air leak time) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 300 |
| Key inclusion criteria | Cases eligible to be included in the trial: all lobectomies, all wedges, all lung biopsies, all operations of pneumothorax. |
| Key exclusion criteria | Lung volume reduction surgery and pneumonectomies. |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiothoracic Surgery
London
SE17EH
United Kingdom
SE17EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2005 | Yes | No |
