Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/03/2016
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 R A Fulcher

ORCID ID

Contact details

Consultant Physician
Medicine for the Elderly
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 287653
katherine.jones@nnuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547130894

Study information

Scientific title

Randomised controlled study of the effect of low flow oxygen on capillary blood gases after acute stroke

Acronym

Study hypothesis

We hypothesise that oxygen supplementation will reduce stroke-induced hyperventilation and normalise blood gases and respiratory rate.

Ethics approval

Norwich Local Research Ethics Committee (UK)

Study design

Randomised controlled trial (unblinded)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Stroke

Intervention

Interventions added as of 18/07/2007:
Patients will be randomised into control and intervention groups by randomly picking up envelopes with predetermined entry to either group. Controls receive routine care without oxygen and the intervention group will receive 2 litres of oxygen per minute via nasal cannula over 24 hours. Pulse oximetry and arterial blood gases will be done on air as baseline. Oxygen will be given to the intervention group continually for the minimum of 24 hours via nasal cannula. Blood gases will be rechecked at the end of the 24-hour period. Pulse oximetry measurements will be recorded throughout the 24-hour period.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Main outcome measures:
1. Changes in pH at the end of experiment
2. Changes in pCO2 at the end of experiment
3. Changes in respiratory rate at the end of experiment

Other relevant outcome measures:
1. Change in blood pressure
2. Change in pulse oximetry

Secondary outcome measures

Added 18/07/2007:
No secondary outcome measures

Overall trial start date

01/06/2003

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Added 18/07/2007:
Patients who are admitted within 24 hours of a presumed vascular stroke (either ischaemic or haemorrhagic) resulting in hospitalisation with significant motor disability (right /left hemiparesis) defined as power 3 out of 5 or less in at least one limb.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

40 (20 into intervention and 20 into control group).

Participant exclusion criteria

Added 18/07/2007:
1. History of Chronic Obstructive Pulmonary Disease (COPD) / asthma with a previous history of CO2 retention
2. Presence of acute illness which affects oxygen saturation / delivery or requires oxygen as part of routine management e.g. anaemia (Hb <10), Pulmonary Embolism (PE) or pneumonia
3. Patients whose stroke occurred as a result of condition other than cerebrovascular event (e.g. brain tumour)
4. Comatose patients with Glasgow Coma Scale (GCS) level < 10

Recruitment start date

01/06/2003

Recruitment end date

30/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospital (UK)

Sponsor details

c/o Ms Kath Jones
Colney Lane
Norwich
NR4 7UY
United Kingdom
+ 44 (0)1603 286286
kath.jones@nnuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nnuh.nhs.uk

Funders

Funder type

Government

Funder name

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital / Norwich Primary Care 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

Publication citations

Additional files

Editorial Notes

14/03/2016: No publications found, verifying study status with principal investigator. On 20/12/2007 the overall trial end date was changed from 01/12/2003 to 30/04/2009.