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
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