Contact information
Type
Scientific
Primary contact
Dr Anita K Simonds
ORCID ID
Contact details
Respiratory Medicine
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8911
a.simonds@rbh.nthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0201109246
Study information
Scientific title
Acronym
Study hypothesis
Aim is to investigate whether starting NIV as an outpatient is as effective in terms of physiological improvement, tolerance and compliance, as standard inpatient initiation. We will also determine the cost and staffing implications of this change in clinical practice.
Ethics approval
Ethics approval was received from the local medical ethics committee before trial recruitment began.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Respiratory: Chronic ventilatory failure
Intervention
24 patients fulfilling entry criteria will be randomised to outpatient or inpatient initiation of NIV using a block randomisation process to ensure balance for diagnosis and age.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
13/02/2002
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
24 patients per year.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
13/02/2002
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Respiratory Medicine
London
SW3 6NP
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
Government
Funder name
Royal Brompton and Harefield 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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18774702
Publication citations
-
Results
Chatwin M, Nickol AH, Morrell MJ, Polkey MI, Simonds AK, Randomised trial of inpatient versus outpatient initiation of home mechanical ventilation in patients with nocturnal hypoventilation., Respir Med, 2008, 102, 11, 1528-1535, doi: 10.1016/j.rmed.2008.07.019.