Prognostic Significance of Pulmonary Function Tests in Adolescent İdiopathic Scoliosis Surgery

NCT ID: NCT06756880

Last Updated: 2025-05-31

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

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-02

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia Pulmonary Function Test, Preoperative Adolescent Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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normal risk

z score is greater than -1.645

Pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

Low risk

z score between -1.645 and -2.5

Pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

Medium risk

z score between -2.5 and -4.0

Pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

High risk

z score of less than -4.0

Pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

Interventions

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Pulmonary function test

Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AIS

Identifier Type: -

Identifier Source: org_study_id

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