Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/02/2010
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 Mark Elliott

ORCID ID

Contact details

St James' University Hospital
Department of Respiratory Medicine
Ward 14
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 6037
mark.elliott@lineone.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H0020 ELLIOTT R&D

Study information

Scientific title

Acronym

Study hypothesis

Acute exacerbations of COPD are a common reason for hospital admission and are a cause of significant mortality. Non-invasive ventilation (NIV) via a face or nasal mask has been shown to reduce mortality and the need for intubation. However the studies have been carried out in units with a particular expertise in the techniques involved. Instituting NIV in a distressed, dispnoeic individual and matching the ventilator to the patients requirements is difficult. The early introduction of NIV is easier (the patient is better able to cooperate and lower, more comfortable inflation pressures can be used) and may interrupt a vicious cycle of deterioration before it is well established. Moreover simpler ventilations, which do not require great expertise and are therefore practical for use in non-specialist units, can be used. We wish to establish whether early NIV can be widely applied, with benefit, in a variety of hospitals.

Ethics approval

Not provided at time of registration

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory tract diseases: Chronic obstructive pulmonary disease

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/12/1996

Overall trial end date

31/12/1998

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

31/12/1996

Recruitment end date

31/12/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James' University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

2003 cost effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/12727767

Publication citations

  1. Cost effectiveness results

    Plant PK, Owen JL, Parrott S, Elliott MW, Cost effectiveness of ward based non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease: economic analysis of randomised controlled trial., BMJ, 2003, 326, 7396, 956, doi: 10.1136/bmj.326.7396.956.

Additional files

Editorial Notes