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
Protocol serial number	N0199104506
Sponsor	Department of Health (UK)
Funder	Royal Berkshire and Battle Hospitals NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised open label
Secondary study design	Randomised controlled trial
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
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Pain scale 2. Patient satisfaction 3. Length of hospital stay and economic savings 4. Complications of drainage
Key secondary outcome measure(s)	1. Time to resolution of pneumothorax 2. Successful resolution 3. Failures requiring surgery
Completion date	30/11/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan