Effect of overnight tube feeding on arterial oxygen saturation

ISRCTN ISRCTN22107328
DOI https://doi.org/10.1186/ISRCTN22107328
Secondary identifying numbers N0106153167
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
11/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dipankar Dutta
Scientific

Elderly Care Department
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesA randomised study to investigate the effect of overnight tube feeding on arterial oxygen saturation.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNot Applicable
InterventionGroup 1: feeding on night one
Group 2: feeding on night two
Intervention typeOther
Primary outcome measureFall in oxygen saturation of 1% or more
Secondary outcome measuresNot provided at time of registration
Overall study start date14/10/2004
Completion date31/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants32
Key inclusion criteria32 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
Key exclusion criteria1. Patients who are terminally ill
2. Patients already on supplemental oxygen for any reason
Date of first enrolment14/10/2004
Date of final enrolment31/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Elderly Care Department
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Gloucestershire R&D Consortium (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2004 Yes No
Results article results 01/11/2006 Yes No