| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75718175 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0547130894 |
| Public title | Randomised controlled study of the effect of low flow oxygen on capillary blood gases after acute stroke |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cardiovascular: Stroke |
| Study hypothesis | We hypothesise that oxygen supplementation will reduce stroke induced hyperventilation and normalise blood gases and respiratory rate |
| Design/methodology | Randomised controlled trial (unblinded) |
| Research ethics review | Information on ethics approval added as of 18/07/2007:
Norwich Local Research Ethics Committee |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Inclusion criteria added as of 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. |
| Participants - exclusion criteria | Exclusion criteria added as of 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 |
| Patient information material |
|
| Anticipated start date | 01/06/2003 |
| Anticipated end date | 30/04/2009 |
| Status of trial | Ongoing |
| Target number of participants | 40 (20 into intervention and 20 into control group). |
| Interventions | Please note that, as of 20 December 2007, this trial has been extended from 1 December 2003 to 30 April 2009.
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. |
| 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 |
| Secondary outcome measure(s) | Added as of 18/07/2007: None |
| Sources of funding | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital / Norwich Primary Care Trust (UK) |
| Sponsor name | Norfolk and Norwich University Hospital (UK) |
| Sponsor details | c/o Ms Kath Jones
Colney Lane
Norwich
United Kingdom
NR4 7UY |
| Sponsor telephone | + 44 (0)1603 286286 |
| Sponsor email | kath.jones@nnuh.nhs.uk |
| Sponsor website | http://www.nnuh.nhs.uk |
| Contact name | Dr R A Fulcher |
| Contact details | Consultant Physician
Medicine for the Elderly
Norfolk and Norwich University Hospital
Colney Lane
Norwich
United Kingdom
NR4 7UY |
| Contact telephone | +44 (0)1603 287653 |
| Contact fax | +44 (0)1603 286428 |
| Contact email | kath.jones@nnuh.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75718175 |
| Date last extracted from ISRCTN register | 17/04/2008 |
