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

ISRCTN	ISRCTN75718175
DOI	https://doi.org/10.1186/ISRCTN75718175
Protocol serial number	N0547130894
Sponsor	Norfolk and Norwich University Hospital (UK)
Funder	East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital / Norwich Primary Care Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 03/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Phyo Mint
Scientific

Consultant Physician
Medicine for the Elderly
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial (unblinded)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled study of the effect of low flow oxygen on capillary blood gases after acute stroke
Study objectives	We hypothesise that oxygen supplementation will reduce stroke-induced hyperventilation and normalise blood gases and respiratory rate.
Ethics approval(s)	Norwich Local Research Ethics Committee (UK)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Added 18/07/2007: No secondary outcome measures
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	40
Key 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.
Key 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
Date of first enrolment	01/06/2003
Date of final enrolment	30/04/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Norfolk and Norwich University Hospital

Norwich
NR4 7UY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/05/2018: Overall trial end date was changed from 30/04/2009. Not published as yet.
16/04/2018: No publications found, verifying study status with principal investigator.
14/03/2016: No publications found, verifying study status with principal investigator.
20/12/2007: the overall trial end date was changed from 01/12/2003 to 30/04/2009.