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Completed

NCT Number: NCT04686214

Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

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.

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heating

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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