Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr CWH Davies

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes