Comparison of Postoprative Electrical Warming Cover and Warmed IV Fluids on Tempreture, Shivering and Physiological Indexes in Patient Undergoing General Anesthesia at Post Anesthesia Care Unit(PACU) in Chosen Hospital Affiliated with Social Affair Organization of Tabriz in1395
This study is a clinical trial that incorporates independent variables being electric overblankets and warm intravenous fluid along with dependent variables including temperature, shivering and physiologic indices.The population in this study includes the patients undergoing general surgery under general anesthesia in 29 Bahman hospital (affiliated to the Social Security Organization ).The research samples will be selected in two stages from the target population.In the first stage a purposive sampling will be carried out. In the second stage the patients are assigned into groups one, two and three based on the results of a draw in which patients randomly pick up numbered envelopes.According to the inclusion criteria, eligible patients will be selected and the objectives of the study will be explained to them. Patient will give written informed consent .Parameters evaluated in all three groups are the peripheral and core body temperatures, physiologic indices (systolic and diastolic blood pressures, mean arterial pressure, heart rate and arterial blood oxygen saturation) and intensity of shivering in the post anesthetic care units that will be measured and recorded upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042527597N1
Registration date:2016-08-04, 1395/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Zakiyeh Imani Sakhlou
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2520
Email address
imani.z@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-07-15, 1395/04/25
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Postoprative Electrical Warming Cover and Warmed IV Fluids on Tempreture, Shivering and Physiological Indexes in Patient Undergoing General Anesthesia at Post Anesthesia Care Unit(PACU) in Chosen Hospital Affiliated with Social Affair Organization of Tabriz in1395
Public title
Prevention of Postoprative Shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Following criteria will be met for the studied patients: Patients aged between 18 and 60 years; Patients who are candidates for general surgery via anesthesia; Patients without restriction on liquid intake, e.g. excluding patients with acute renal or heart failure; Patients who do not suffer from middle ear infection or from perforation of the eardrum; Patients whose physical status falls in Class 1 or 2, according to the classification of the American Society of Anesthesiologists (ASA).
Exclusion Criteria: Patients with core hypothermia or hyperthermia upon intervention; Patients who need blood transfusion during operation; Patients with duration of surgery longer than three hours; Patients who are not extubated or are not transferred to the recovery room post operation at the discretion of the anesthesiologist; Patients who receive vasoconstrictor drugs during surgery; Patient who receive Succinil Colin for induction of anesthesia.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
nursing & midwifery faculty of shahid beheshti university of medical science
Street address
shahid beheshti nursing & midwifery faculty-niyayesh intersection- vally asr street-tehran
City
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SBMU.PHNM.1394.341
Health conditions studied
1
Description of health condition studied
postanesthesia shivering
ICD-10 code
I98
ICD-10 code description
Other disorders of circulatory system in diseases classified elsewhere,
Primary outcomes
1
Description
peripheral body tempreture
Timepoint
upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit
Method of measurement
by digital thermometer EmsiG- CT20 made in Germany
2
Description
core body tempreture
Timepoint
upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit.
Method of measurement
by digital infrared thermometer, EmsiG - CT30 made in Germany to measure the tympanic membrane temperature.
3
Description
physiologic indices
Timepoint
upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit.
Method of measurement
measured by Saadat vital signs monitors, Model Alborz-B produced by Pooyandegan Rah Saadat Company of Iran.
4
Description
post oprative shivering
Timepoint
every 15 minutes at post anesthesia care unit
Method of measurement
the scale described by Crossley and Mahajanto
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group involving electric blankets after surgery, Beurer HD90 blankets (made in Germany) will be used. The blankets come in 130cmx180cm dimensions and could be adjusted for six different temperatures. They feature automatic shutdown system, overheating protection and performance display light. Additionally, these blankets are certified by European Oeko-Tex which approves the textile safety for the consumers. In this group, the blanket will be used after surgery such that it will be prepared and switched on fifteen minutes prior to admission of the patient into the post anesthetic care unit. Upon arrival of the patients into the recovery unit, the blankets will be laid over them and left until the patients are discharged from the recovery unit.
Category
Prevention
2
Description
In the second experimental group in which warm intravenous fluid is used during surgery, the required liquid intake of the patient will be determined. Once the patient is transferred on to the operating table, the required liquid will be heated to 37 °C under supervision of an anesthesiologist using Biggler Warmer – BW585 assembled in Iran. To connect the intravenous fluid to the warmer set an extension tube is used having the same length for all patients.
Category
Prevention
3
Description
In the control group, patients will receive routine care. In the studied hospital, patients receive intravenous fluid in ambient temperature during surgery and upon completion of the operation, a usual blanket is laid over patients before transferring them into the recovery room.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Zakiyeh Imani Sakhlou
Street address
29 Bahman Hospital, 29 Bahman Boulevard , Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ms Simbar
Street address
Shahid Beheshti Nursing & Midwifery Faculty, Niyayesh Intersection, Vali Asr street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehryar Yoldashkhan
Position
MSc/board of science
Other areas of specialty/work
Street address
Shahid Beheshti Nursing & Midwifery Faculty, Niyayesh Intersection, Vali Asr Street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 88 20251
Email
yoldashkhan@gmail.com
Web page address
www.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sahid Beheshti University of Medical Sciences
Full name of responsible person
Mehryar Yoldashkhan
Position
MSc/board of science
Other areas of specialty/work
Street address
Shahid Beheshti Nursing & Midwifery Faculti, Niyayesh Intersection, Vali Asr Street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 88202521
Email
yoldashkhan@gmail.com
Web page address
www.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zakiyeh Imani Sakhlou
Position
MSc/University Student
Other areas of specialty/work
Street address
Shahid Beheshti Uursing & Midwifery Faculty, Niyayesh Intersection, Vali Asr Stret, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 88202521
Email
imani.z@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)