The effect of a protective ventilation strategy, fine tuned using pulmonary mechanics monitoring, on outcome from severe acute respiratory failure in children
| ISRCTN | ISRCTN27628446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27628446 |
| Protocol serial number | N0012027897 |
| Sponsor | Department of Health (UK) |
| Funder | Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/09/2009
- 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 M Schindler
Scientific
Scientific
PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| Phone | +44 (0)20 7813 8213 |
|---|---|
| Margrid.Schindler@gosh-tr.nthames.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does the use of pulmonary function testing to adjust ventilation parameters improve outcome from acute paediatric respiratory failure? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Acute paediatric respiratory failure |
| Intervention | Please note that as of 16/09/09 the status of this record was changed to "Stopped" due to lack of funding. There is no plan to recommence the trial. Randomised controlled trial. Random allocation to (A) Pulmonary function testing (B) Standard care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival at 28 days. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/05/2003 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Key inclusion criteria | Children with severe acute respiratory failure. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 24/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
PICU
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |