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

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Phone +44 (0)20 7813 8213
Email Margrid.Schindler@gosh-tr.nthames.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes 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) studiedRespiratory: Acute paediatric respiratory failure
InterventionPlease 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 typeOther
Primary outcome measure(s)

Survival at 28 days.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date24/05/2003
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Key inclusion criteriaChildren with severe acute respiratory failure.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/1999
Date of final enrolment24/05/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

PICU
London
WC1N 3JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan