Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106153167
Study information
Scientific title
Acronym
Study hypothesis
A randomised study to investigate the effect of overnight tube feeding on arterial oxygen saturation.
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
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Not Applicable
Intervention
Group 1: feeding on night one
Group 2: feeding on night two
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Fall in oxygen saturation of 1% or more
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/10/2004
Overall trial end date
31/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
32 patients receiving tube feeding:
1. Adult patients above the age of 18 years, no upper age limit
2. Diagnosis of ischaemic or haemorrhagic stroke within the last 18 weeks
3. Patient fed by NG or PEG tube
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
32
Participant exclusion criteria
1. Patients who are terminally ill
2. Patients already on supplemental oxygen for any reason
Recruitment start date
14/10/2004
Recruitment end date
31/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Elderly Care Department
Gloucester
GL1 3NN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gloucestershire R&D Consortium (UK), NHS R&D Support Funding
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
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15292036
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16951261
Publication citations
-
Results
Dutta D, Bannerjee M, Chambers T, Is tube feeding associated with altered arterial oxygen saturation in stroke patients?, Age Ageing, 2004, 33, 5, 493-496, doi: 10.1093/ageing/afh183.
-
Results
Dutta D, Wood T, Thomas R, Asrar Ul Haq M, Is overnight tube feeding associated with hypoxia in stroke?, Age Ageing, 2006, 35, 6, 627-629, doi: 10.1093/ageing/afl099.