Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0199104506
Study information
Scientific title
Assessment of new portable chest drain system versus conventional chest tube drainage in patients with primary spontaneous pneumothorax requiring pleural drainage
Acronym
Study hypothesis
Whether patients with pneumothorax can be managed effectively as outpatients with new portable chest drain (Vent).
Ethics approval
Not provided at time of registration
Study design
Randomised open label
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
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 trial start date
10/08/2001
Overall trial end date
30/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/08/2001
Recruitment end date
30/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Berkshire & Battle Hospitals NHS Trust
Reading
RG30 1AG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Berkshire and Battle Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list