Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130418
Study information
Scientific title
Acronym
Study hypothesis
It will help to determine the appropriate treatment parameter targets and in turn the most appropriate type of ventilator for patients undergoing non-invasive ventilation for chest wall and neuromuscular weakness. In addition it will help understanding the pathogenesis of respiratory failure in such patients
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
Other
Trial type
Not Specified
Patient information sheet
Condition
Respiratory: Non-invasive ventilation
Intervention
Randomised controlled trial; Before-after trial Random allocation to [a] treatment a [b] treatment b
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Delivered tidal volume
2. minute ventilation
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
16/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients will be asked to volunteer for the study from a patient base of approximately 70 patients whom are already established on non-invasive ventilation at home.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
70
Participant exclusion criteria
1. Change in ventilator or its settings within last 6 weeks
2. recent deterioration in condition
3. rapidly progressive disease
4. patient refusal
Recruitment start date
01/06/2002
Recruitment end date
16/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Respiratory Medicine (ward 14)
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
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
Funder name
None
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17601720
Publication citations
-
Results
Tuggey JM, Delmastro M, Elliott MW, The effect of mouth leak and humidification during nasal non-invasive ventilation., Respir Med, 2007, 101, 9, 1874-1879, doi: 10.1016/j.rmed.2007.05.005.