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Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

NCT ID: NCT04686214

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia; Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

Group Type EXPERIMENTAL

heating

Intervention Type PROCEDURE

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

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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heating

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nur Canbolat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University, Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34665055 (View on PubMed)

Other Identifiers

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2019/145

Identifier Type: -

Identifier Source: org_study_id