Prognostic Significance of Pulmonary Function Tests in Adolescent İdiopathic Scoliosis Surgery

NCT06756880 | Completed

• 1 other identifier: AIS
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Pulmonary Function Test, Preoperative; Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; Preoperative Pulmonary Function Test

Outcome Measures

Primary Outcomes (1)

• Need for intensive care admission

  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.

  2019 - 2024

Secondary Outcomes (7)

• Hospital stay

  2019 - 2024

• Need for blood transfusion

  2019 - 2024

• Mortality status

  2019 - 2024

• İnotropic support requirement

  2019 - 2024

• Cobb angle

  2019 - 2024

Study Arms (4)

normal risk

z score is greater than -1.645

Diagnostic Test: Pulmonary function test

Low risk

z score between -1.645 and -2.5

Diagnostic Test: Pulmonary function test

Medium risk

z score between -2.5 and -4.0

Diagnostic Test: Pulmonary function test

High risk

z score of less than -4.0

Diagnostic Test: Pulmonary function test

Interventions

Pulmonary function test DIAGNOSTIC_TEST

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

High risk; Low risk; Medium risk; normal risk

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 10-18 who underwent posterior spinal fusion surgery under general anesthesia due to Adolescent Idiopathic Scoliosis (AIS) will be included in the study. Exclusion criteria were determined as ASA (American Society of Anesthesiologists) score of 4 and above, body mass index \>35 kg/m², mental retardation, Need for Bilevel Positive Airway Pressure (BPAP) before surgery, patients who could not successfully complete preoperative respiratory function tests, presence of tracheostomy and revision surgeries.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Respiratory Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation specialist doctor

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: January 2, 2025
• Primary Completion: February 21, 2025
• Study Completion: May 30, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)