Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

NCT04686214 | Completed

• 1 other identifier: 2019/145
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  surgery time (approximately 2 hours)

Study Arms (2)

study group

EXPERIMENTAL

Procedure: heating

control group

NO INTERVENTION

Interventions

heating PROCEDURE

patients were aggressively warmed using multiple heating methods such as pressurized air heater and intravenous fluid heater

study group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34665055 DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

Heating

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 28, 2020
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)