Back to resultsBody Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
Primary Purpose
Hypothermia; Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
heating
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia; Anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents
Exclusion Criteria:
- Patients with body weight <35kg, morbid obesity (BMI> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate
Sites / Locations
- Istanbul University, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
Outcomes
Primary Outcome Measures
blood loss in the group of patients who are kept normothermic
to test that blood loss is reduced in the group of patients who are kept normothermic by applying aggressive multiple warming method compared to the patient group in which mild-moderate hypothermia was allowed by using a standard single heater in an operation that poses a high risk for bleeding and hypothermia, such as AIS deformity correction surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT04686214
First Posted
December 18, 2020
Last Updated
December 24, 2020
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT04686214
Brief Title
Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
Official Title
The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
heating
Intervention Description
patients were aggressively warmed using multiple heating methods such as pressurized air heater and intravenous fluid heater
Primary Outcome Measure Information:
Title
blood loss in the group of patients who are kept normothermic
Description
to test that blood loss is reduced in the group of patients who are kept normothermic by applying aggressive multiple warming method compared to the patient group in which mild-moderate hypothermia was allowed by using a standard single heater in an operation that poses a high risk for bleeding and hypothermia, such as AIS deformity correction surgery.
Time Frame
surgery time (approximately 2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents
Exclusion Criteria:
Patients with body weight <35kg, morbid obesity (BMI> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate
Facility Information:
Facility Name
Istanbul University, Faculty of Medicine
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34665055
Citation
Gozubuyuk E, Aygun E, Basaran I, Canbolat N, Cavdaroglu B, Akgul T, Buget MI. Effects of Changes in Body Temperature on Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery. Ther Hypothermia Temp Manag. 2022 Sep;12(3):146-154. doi: 10.1089/ther.2021.0016. Epub 2021 Oct 18.
Results Reference
derived
Learn more about this trial
Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
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