- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756880
Prognostic Significance of Pulmonary Function Tests in Adolescent İdiopathic Scoliosis Surgery
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ankara, Çankaya
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Ankara, Ankara, Çankaya, Turkey, 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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