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临床试验/NCT06756880
NCT06756880已完成不适用

The Role of Preoperative Pulmonary Function Tests in Predicting Postoperative Intensive Care Need in Adolescent Idiopathic Scoliosis Surgery: A Retrospective Cohort Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2025年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
Need for intensive care admission

研究概览

简要总结

Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine, the etiology of which is not clearly known, and can be seen from the age of 10 until the skeletal system matures. The Scoliosis Research Society (SRS) defines AIS as vertebral rotation and a Cobb angle of 10° or greater. Its incidence varies between 0.47% and 5.2%. It is more common in women than in men. In patients with a Cobb angle greater than 40° or who are not yet bone-mature and who are continuously progressing, surgical intervention is often performed with posterior spinal fusion. Scoliosis negatively affects not only the appearance of patients but also their lung functions through differentiation in thoracic morphology and progression of spinal curvature. The severity of this restrictive pattern in lung functions can be assessed with pulmonary function tests (PFT). However, this test requires patient cooperation and is particularly difficult to perform in patients with cognitive dysfunction. Despite studies recommending the use of pulmonary function tests in preoperative risk assessment, the literature shows inconsistency in predicting the need for postoperative intubation and mechanical ventilation.

In this study, the effect of preoperative pulmonary function tests (PFT) performed before AIS surgery on the need for intensive care admission will be evaluated. In addition, the potential relationships between PFT results and intraoperative and postoperative blood transfusion needs, postoperative intubation needs, hospital stay, mortality status, inotropic support needs, Cobb angle, scoliosis location, and the number of affected vertebrae will be investigated.

详细描述

After local ethics committee approval, patients' age, gender, weight, American Society of Anesthesiologists (ASA) physical status, additional diseases, localization of scoliosis, number of vertebrae affected, Cobb angle and presence of chronic lung disease will be recorded within the scope of demographic data.

Cobb angle or lateral spinal curvature will be measured and recorded on the spine radiograph closest to the date of surgery. In terms of preoperative respiratory function tests, the results performed closest to the date of surgery and accepted as successful according to American Thoracic Society standards will be analyzed. In this context, forced vital capacity (FVC) percentage of normal, forced expiratory volume in 1 second (FEV1) percentage of normal, and FEV1/FVC ratios will be recorded. In the presence of an obstructive or restrictive pattern, FEV1/FVC or FVC Z-scores will be examined and evaluated as normal, mild, moderate or severe in accordance with European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines. The Z-score shows how much the individual's measured value deviates from the reference population determined according to factors such as ethnicity, gender, age, and height. A z-score greater than -1.645 is considered normal, a z-score between -1.645 and -2.5 is considered mild, a z-score between -2.5 and -4.0 is considered moderate, and a z-score below -4.0 is considered severe.

The recorded data will be evaluated by considering the need for intensive care admission, need for intraoperative and postoperative blood transfusion, need for postoperative intubation, length of hospital stay, mortality status, need for inotropic support, Cobb angle, location of scoliosis and number of affected vertebrae. Postoperative intubation status will be defined as patients brought to the ICU without extubation or re-intubated within 24 hours.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 10-18
  • Patients who underwent posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis under general anesthesia

排除标准

  • Body mass index >35 kg/m²
  • ASA (American Society of Anesthesiologists) score of 4 and above
  • Patients who have undergone revision surgery
  • Patients with mental retardation
  • Need for Bilevel Positive Airway Pressure (BPAP) before surgery
  • Patients who could not successfully complete preoperative respiratory function tests
  • Preoperative tracheostomy presence
  • Patients with vertebral anomaly due to a secondary reason
  • Patients with a diagnosed syndrome

结局指标

主要结局

Need for intensive care admission

时间窗: 2019 - 2024

The primary outcome of the study was to evaluate the effect of preoperative lung function tests performed before adolescent idiopathic scoliosis surgery on the need for postoperative intensive care admission.

次要结局

  • Hospital stay(2019 - 2024)
  • Need for blood transfusion(2019 - 2024)
  • Mortality status(2019 - 2024)
  • İnotropic support requirement(2019 - 2024)
  • Cobb angle(2019 - 2024)
  • Location of scoliosis and number of affected vertebrae(2019 - 2024)
  • Need for postoperative intubation(2019 - 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Ankara City Hospital Bilkent

研究点 (1)

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