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Evaluation of the Effect of Hypothermia Prevention Program on, Recovery Time, Shivering and Hemodynamic Status in Pediatric Undergoing Orthopedic Surgery Under General Anesthesia

Protocol summary

Study aim
Determining of the effect of hypothermia prevention program on recovery time, shivering and hemodynamic status in children who are candidates for orthopedic surgery under general anesthesia
Design
This study is a randomized, single-blind clinical trial consisting of control and intervention groups. Which will be performed on 60 patients who are divided into two groups of 30 people by simple random method using 60 sealed envelopes. The patient randomly selects an envelope if the letter A is in the intervention group and if it is B in the control group.
Settings and conduct
This project was performed in the operating room of Allameh Behlool Gonabadi Hospital and people in the control group received routine care to control the temperature, but in the intervention group, fluids were heated for infusion and the recovery bed was heated. Blinding is done only by the patient and the study will be a blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children undergoing surgery with a minimum of 30 minutes, age 3 to 18 years, general anesthesia, ASA class 1 and 2, body temperature 36 to 37 ° C, Exclusion criteria: significant decrease in blood pressure during surgery, temperature above 37.5 ° C or below 36 ° C, blood and blood products, Drugs other than fentanyl during surgery
Intervention groups
In the control group, the child will routinely receive operating room care, including prep, drop, and infusion of operating room temperature fluids. In the intervention group, a heated disinfectant solution up to 32 ° C is used for skin disinfection and 37 ° C fluids are used for intravenous infusion. After surgery, patients are transferred to a recovery bed that was warmed before the patient was transferred to recovery.
Main outcome variables
Determining the incidence of hypothermia, shivering, recovery time, hemodynamic status in both groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200501047254N2
Registration date: 2022-02-23, 1400/12/04
Registration timing: prospective

Last update: 2022-02-23, 1400/12/04
Update count: 0
Registration date
2022-02-23, 1400/12/04
Registrant information
Name
Fatemeh Pouladkhay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3360
Email address
pouladkhay.fatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Hypothermia Prevention Program on, Recovery Time, Shivering and Hemodynamic Status in Pediatric Undergoing Orthopedic Surgery Under General Anesthesia
Public title
Evaluation of the Effect of Hypothermia Prevention Program in Children Undergoing Orthopedic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children undergoing surgery with a minimum time of 30 minutes Age 3 to 18 years The patients who are candidate for general anesthesia Patients with ASA class 1 and 2 Body temperature 36.5 to 37 ° C No drug addiction Reluctance to continue participating in the project
Exclusion criteria:
Occurrence of any condition that affects the patient's normal course of anesthesia and surgery, such as excessive bleeding and cardiac arrest during surgery Significant decrease in blood pressure during surgery (20% decrease in blood pressure compared to before anesthesia) Temperatures above 37.5 ° C or below 36 ° C before surgery Receiving blood and blood products during surgery Take corticosteroids Receiving non-steroidal analgesics and magnesium sulfate Prohibition to control body temperature through the tympanic membrane Receiving drugs other than fentanyl during surgery
Age
From 3 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is simple randomization. For random allocation of participants, 60 envelopes are prepared and in each envelope the names of groups, A or B are placed evenly. Then the patient with the inclusion criteria randomly selects an envelope and according to the name of the group that if A was in the intervention group and if B was in the control group and until the last sample will be done in the same way and the necessary measures for the group Will be done.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blind. So that the patient is not aware of the type of measures that will be performed for him, but since the measurement of parameters is done by the researcher, the researcher does not blind.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Operating Room Department, School of Paramedical Sciences, Gonabad University of Medical Sciences, Asian Roadside, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793813
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
IR.GMU.REC.1400.203

Health conditions studied

1

Description of health condition studied
Hypothermia of newborn
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Hypothermia
ICD-10 code
P80
ICD-10 code description
Hypothermia of newborn

Primary outcomes

1

Description
Hypothermia
Timepoint
The measurement of the variable in eight shifts will include the following: 5 minutes before the start of anesthesia, 5 minutes after induction of anesthesia and one minute before the start of surgery, 30 minutes after the start of surgery, after the end of surgery, at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored
Method of measurement
Tympan thermometer

2

Description
Hemodynamic status
Timepoint
The measurement of the variable in eight shifts will include the following: 5 minutes before the start of anesthesia, 5 minutes after induction of anesthesia and one minute before the start of surgery, 30 minutes after the start of surgery, after the end of surgery, at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored
Method of measurement
Anesthesia monitor

3

Description
Shivering
Timepoint
The measurement of the variable at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored
Method of measurement
Mahajan and Crossley criteria will be used to evaluate the incidence of postoperative shivering. The number zero indicates the patient without shivering, the number 1 = mild shivering (hair straightening), the number 2 = moderate shivering (muscle tremors visible in one group of muscles), the number 3 = severe shivering) muscle tremors in more than one group of Muscles but not in the whole body (generalized) and the number 4 - will show very strong vibration (generalized body vibration).

4

Description
Recovery time
Timepoint
From the moment of arrival until the patient is discharged from recovery
Method of measurement
Timer

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Performing routine care in the operating room to maintain the patient's temperature and prevent hypothermia
Category
Prevention

2

Description
Intervention group: In this group, heated solutions up to 32 ° C are used for skin disinfection, heated solutions up to 37 ° C are used for intravenous infusion, and before transferring the patient to recovery, the recovery bed and blanket will be heated by the warmer.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Fatemeh Pouladkhay
Street address
Allameh Behlool Gonabadi Hospital, Parstar Blvd., Saadi St., Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
pouladkhay.fatemeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Leila Sadeghi Moghadam
Street address
Deputy of research and technology, Gonabad University of Medical Sciences, Asian Roadside, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
pouladkhay.fatemeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Instructor, faculty member of the operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of Operating Room, School of Paramedical Sciences, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
pouladkhay.fatemeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Instructor, member of the operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of Operating Room, School of Paramedical Sciences, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
pouladkhay.fatemeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Instructor, member of the operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of Operating Room, School of Paramedical Sciences, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
pouladkhay.fatemeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be published along with the working method and executive protocols after the end of the study. Patients' personal information will be kept secure and only the results of the intervention will be available.
When the data will become available and for how long
Access period starts from the second half of 1401
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only the results of the study will be available for other researchers to cite.
From where data/document is obtainable
Author responsible for the scientific study
What processes are involved for a request to access data/document
Contact the responsible author via email.
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