A comparison of high rate, low tidal volume ventilation and conventional ventilation in the management of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS)
| ISRCTN | ISRCTN55387780 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55387780 |
| Secondary identifying numbers | N0436125551 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/09/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H Buglass
Scientific
Scientific
Anaesthetics Department
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2002 |
| Completion date | 01/11/2004 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics Department
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
