The objective of present study is to investigate metabolic and hemodynamic change after using tourniquet in upper extremity surgery for release contracture after burn injury. 20 patients, aged 13-60 years with upper extremity burn, scheduled for upper extremity surgery due to burn contracture and need tourniquet application are included in this study. Two venous catheters (one proximal to tourniquet and the other in contralateral arm) will be inserted. PH, po2, Hco3, lactate, blood pressure, and heart rate will be measured 10 seconds and also 1, 3, and 5 minutes after opening of the tourniquet.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811271605N8
Registration date:2010-05-15, 1389/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-15, 1389/02/25
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of metabolic and hemodynamic change after using tourniquet in upper extremity surgery to release contracture after burn injury
Public title
Investigation of metabolic and hemodynamic change after using tourniquet in upper extremity surgery to release contracture after burn injury
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Age 13-60, upper extremity burn, candidate to surgery due to burn complication using tourniquet for 30 to 60 minutes during surgery
Exclusion criteria: presence of open wound in other sites of body, cardio vascular disease, patients under drug treatments
Age
From 13 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Postal code
Approval date
empty
Ethics committee reference number
4848-88-CT
Health conditions studied
1
Description of health condition studied
hemodynamic change
ICD-10 code
R09.8
ICD-10 code description
Other specified symptoms and signs involving the circulatory and respiratory systems
2
Description of health condition studied
metabolic change
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Arterial blood PH
Timepoint
10 second, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
blood gas instrument
2
Description
Arteial PO2
Timepoint
10 second, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
blood gas instrument
3
Description
Serum lactate
Timepoint
10 second, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
blood gas instrument
4
Description
Serum bicarbonate
Timepoint
before opening of tourniquet, 10 seconds, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
blood gas instrument
5
Description
blood pressure
Timepoint
before opening of tourniquet, 10 seconds, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
by sphyngomanometer
6
Description
heart rate
Timepoint
before opening of tourniquet, 10 seconds, 1, 3, and 5 minutes after opening tourniquet
Method of measurement
by checking heart bit in a minute
Secondary outcomes
empty
Intervention groups
1
Description
using tourniquet for 30 to 60 minutes
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotb-eddin Burn Center
Full name of responsible person
Ali Akbar Mohammadi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Burn research center, Fakhrabad Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Burn reaserch center
Full name of responsible person
Ali akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Burn reaserch center, Fakhrabad Street, Shiraz,
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Burn reaserch center
Full name of responsible person
Masoomeh Kherad
Position
Manager of Shiraz Burn Reaserch Center/Nurse
Other areas of specialty/work
Street address
Fakhrabad St., Ghotbeddin Hospital, Shiraz Burn Reaserch Center
City
Shiraz
Postal code
Phone
+98 71 1820 8880
Fax
Email
burnres1@sums.ac.ir
Web page address
www.burnres.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)