Prognostic Significance of Pulmonary Function Tests in Adolescent İdiopathic Scoliosis Surgery

May 30, 2025 updated by: Gökhan Erdem, Ankara City Hospital Bilkent

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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ankara, Çankaya
      • Ankara, Ankara, Çankaya, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal risk
z score is greater than -1.645
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 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 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 results performed closest to the date of surgery and considered successful according to American Thoracic Society standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for intensive care admission
Time Frame: 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.
2019 - 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and hospital stay
2019 - 2024
Need for blood transfusion
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and need for blood transfusion
2019 - 2024
Mortality status
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and mortality status
2019 - 2024
İnotropic support requirement
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and inotropic support requirement
2019 - 2024
Cobb angle
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and cobb angle
2019 - 2024
Location of scoliosis and number of affected vertebrae
Time Frame: 2019 - 2024
Investigation of the potential relationship between pulmonary function test results and location of scoliosis and number of affected vertebrae
2019 - 2024
Need for postoperative intubation
Time Frame: 2019 - 2024
Investigation of the possible relationship between lung function test results and the need for postoperative intubation Postoperative intubation status was defined as patients brought to the ICU without extubation or reintubated within 24 hours.
2019 - 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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