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Clinical Trials/NCT04686214
NCT04686214CompletedNot Applicable

The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Istanbul University2 sites in 1 country39 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
2
Primary Endpoint
blood loss in the group of patients who are kept normothermic

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

blood loss in the group of patients who are kept normothermic

Time Frame: surgery time (approximately 2 hours)

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nur Canbolat

Principal Investigator

Istanbul University

Study Sites (2)

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