Condition category
Not Applicable
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dipankar Dutta

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

  2. 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.

Additional files

Editorial Notes