Effect of high percent oxygen therapy in compared without oxygen therapy on rehabilitation in the first 12 hours of admission in patients with stroke: a randomized clinical trial
Objective: To assess the effect of high percent oxygen therapy on rehabilitation in the first 12 hours of admission in stroke patients Design: Randomized controlled trial. Setting: The eligible patients with stroke who will refer to neurology ward of Farshchian hospital in 2012. Inclusion criteria: (a) Age greater than 40 and lesser than 70 years; (b) patients who have GCS greater than 12 and patients that have only brain damage also their airway protective reflexes are normal; (c) The patients that their brain CT scans show pure ischemic and hemorrhagic stroke without need to surgery; (d) The patients that do not have acute subdural hematoma and cerebellar hemorrhage; (e) Elapsed time from accident to starting treatment is less than 12 hours; (f) Patients who are in hemodynamically stable condition and their blood pressure is less than 170/90. Exclusion criteria: (a) patients who have underlying cardiovascular disease, diabetes mellitus, renal failure; (b) Patients who need tracheal intubation at the time of hospital admission; (c) Patients with blood pressure less than 90/60; (d) having documented hypoxia; (e) Patients who had successful CPR; (f) Patients who have history of previous stroke. Intervention: 26 patients will receive 50% oxygen in the first 12 hours of admission. Control: 26 patients will receive routine medications without oxygen. Primary outcome: Good recovery and less number of complications in the first day of admission, before discharge, and six months after discharge using ranking scale and Barthel index
General information
Acronym
GCS: Glascow coma scale
IRCT registration information
IRCT registration number:IRCT201212199647N2
Registration date:2013-11-03, 1392/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-03, 1392/08/12
Registrant information
Name
Abbas Taher
Name of organization / entity
Hamadan Medical Sience University
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0063
Email address
a.taher@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology Hamadan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high percent oxygen therapy in compared without oxygen therapy on rehabilitation in the first 12 hours of admission in patients with stroke: a randomized clinical trial
Public title
Effect of high percent oxygen therapy in compared without oxygen therapy on rehabilitation in the first 12 hours of admission in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) Age greater than 40 and lesser than 70 years; (b) patients who have GCS greater than 12 and patients that have only brain damage also their airway protective reflexes are normal; (c) The patients that their brain CT scans show pure ischemic and hemorrhagic stroke without need to surgery; (d) The patients that do not have acute subdural hematoma and cerebellar hemorrhage; (e) Elapsed time from accident to starting treatment is less than 12 hours; (f) Patients who are in hemodynamically stable condition and their blood pressure is less than 170/90. Exclusion criteria: (a) patients who have underlying cardiovascular disease, diabetes mellitus, renal failure; (b) Patients who need tracheal intubation at the time of hospital admission; (c) Patients with blood pressure less than 90/60; (d) having documented hypoxia; (e) Patients who had successful CPR; (f) Patients who have history of previous stroke.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee, Hamadan university of medical sciences
Street address
Hamadan university of medical science, Shahid Fahmide Street
City
Hamadan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
D/T/16/35/9/4582
Health conditions studied
1
Description of health condition studied
haemorrhagic or ischemic stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Good recovery and less complication
Timepoint
First day of admission, before discharge, six months after discharge
Method of measurement
Ranking scale, Barthel index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive 50% oxygen in the first 12 hours of admission
Category
Treatment - Drugs
2
Description
Control group: will receive routine medications without oxygen
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital Hamadan Iran
Full name of responsible person
abbas taher MD,anesthetist,fellowship of critical care medicine
Street address
Besat hospital, department of anesthesia and critical care medicine, hamedan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-chancellor of research and Technology, Hamadan medical university
Full name of responsible person
Ahmad Tavilani
Street address
Hamadan University of medical science, Sahid Fahmide Street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of research and Technology, Hamadan medical university
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Anesthesia and intensive care department
Full name of responsible person
Abbas Taher
Position
MD,Anesthetist ,Fellowship Of Critical Care Medicine,Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital,Hamadan
City
Hamadan
Postal code
Phone
+98 81126400634
Fax
Email
a.taher@umsha.ac.ir; t_anesthesia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesia and intensive care department
Full name of responsible person
Abbas Taher
Position
MD,anesthetist,Fellowship Of Critical Care,Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital Hamadan
City
Hamadan
Postal code
Phone
+98 81126400634
Fax
Email
a.taher@umsha .ac.ir; t_anesthesia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia and intensive care department
Full name of responsible person
Abbas Taher
Position
MD,Aesthetist And Fellowship Of Critical Care,Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital ,Hamadan
City
Hamadan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)