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
Secondary identifying numbers	N0013145914

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

Cardiothoracic Surgery
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE17EH
United Kingdom

Phone	+44 (0)20 7188 7188
Email	nelson.a@bigfoot.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. Time to last bubble (air leak time) 2. Time to removal of drain 3. Time to discharge home
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2002
Completion date	01/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Cardiothoracic Surgery

London
SE17EH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK), Own Account

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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