Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H Buglass

ORCID ID

Contact details

Anaesthetics Department
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436125551

Study information

Scientific title

Acronym

Study hypothesis

Primary aim of the study is to show that there is an increase in ventilator free days in first 28 days using high respiratory rate, low tidal volume ventilation technique compared to standard ventilation techniques.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute respiratory distress

Intervention

Randomised controlled trial. Random allocation to:
1. New Treatment - high respiratory rate, low tidal volume ventilation
2. Standard Treatment - conventional ventilation

13/09/2012: Please note that this trial was stopped due to a lack of participants.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Ventilator free days in first 28 days
2. Reduced production of IL-6, IL-8 IL-10 Neutrophil count and tumour necrosis factor (TNF) in response to ventilation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2002

Overall trial end date

01/11/2004

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Patients intubated and receiving mechanical ventilation who have an acute decrease in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen reaching the criteria for ALI and ARDS set by the American-European consensus conference committee

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/11/2002

Recruitment end date

01/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics Department
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching 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