Assessment of new portable chest drain system versus conventional chest tube drainage in patients with primary spontaneous pneumothorax requiring pleural drainage

ISRCTN	ISRCTN76867469
DOI	https://doi.org/10.1186/ISRCTN76867469
Secondary identifying numbers	N0199104506

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr CWH Davies
Scientific

Department of Respiratory Medicine
Royal Berkshire & Battle Hospitals NHS Trust
Abbey Block
Oxford Road
Reading
RG30 1AG
United Kingdom

Study design	Randomised open label
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Assessment of new portable chest drain system versus conventional chest tube drainage in patients with primary spontaneous pneumothorax requiring pleural drainage
Study objectives	Whether patients with pneumothorax can be managed effectively as outpatients with new portable chest drain (Vent).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Pleural drainage
Intervention	Randomised open label design standard in patient drain or the Vent with option of early discharge. New portable chest drain system versus conventional chest tube drainage.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	1. Pain scale 2. Patient satisfaction 3. Length of hospital stay and economic savings 4. Complications of drainage
Secondary outcome measures	1. Time to resolution of pneumothorax 2. Successful resolution 3. Failures requiring surgery
Overall study start date	10/08/2001
Completion date	30/11/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/08/2001
Date of final enrolment	30/11/2004

Royal Berkshire & Battle Hospitals NHS Trust

Reading
RG30 1AG
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Hospital/treatment centre

Royal Berkshire and Battle Hospitals NHS Trust (UK)

No information available

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