AnesthesiaNCT06756880
Prognostic Significance of Pulmonary Function Tests in Adolescent İdiopathic Scoliosis Surgery
An observational study of Anesthesia and Pulmonary Function Test, Preoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anesthesia, Pulmonary Function Test, Preoperative, Adolescent Idiopathic Scoliosis
- What is being tested?
- Pulmonary function test
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age range 10-18
- Patients who underwent posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis under general anesthesia
Who cannot join
- 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
Show all 9Show fewer
- Preoperative tracheostomy presence
- Patients with vertebral anomaly due to a secondary reason
- Patients with a diagnosed syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya, 06800
About this study
Official title: 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.
Read the 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.
- Being tested
- Pulmonary function test
- Keywords
- Adolescent Idiopathic Scoliosis, Preoperative Pulmonary Function Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testDiagnostic test
Pulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards
| Study group | Role | What they receive |
|---|---|---|
| normal risk | z score is greater than -1.645 Receives: Diagnostic Test: Pulmonary function test | |
| Low risk | z score between -1.645 and -2.5 Receives: Diagnostic Test: Pulmonary function test | |
| Medium risk | z score between -2.5 and -4.0 Receives: Diagnostic Test: Pulmonary function test | |
| High risk | z score of less than -4.0 Receives: Diagnostic Test: Pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2019 - 2024
Secondary outcomes (7)
Hospital stay
Investigation of the potential relationship between pulmonary function test results and hospital stay
Measured: 2019 - 2024
Need for blood transfusion
Investigation of the potential relationship between pulmonary function test results and need for blood transfusion
Measured: 2019 - 2024
Mortality status
Investigation of the potential relationship between pulmonary function test results and mortality status
Measured: 2019 - 2024
İnotropic support requirement
Investigation of the potential relationship between pulmonary function test results and inotropic support requirement
Measured: 2019 - 2024
Cobb angle
Investigation of the potential relationship between pulmonary function test results and cobb angle
Measured: 2019 - 2024
Location of scoliosis and number of affected vertebrae
Investigation of the potential relationship between pulmonary function test results and location of scoliosis and number of affected vertebrae
Measured: 2019 - 2024
Need for postoperative intubation
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.
Measured: 2019 - 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start2 Jan 2025
- Primary completion21 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Erdem, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756880
- Sponsor's protocol ID
- AIS
- Status last verified
- May 2025
- First submitted
- 24 Dec 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdem G, Aksoy SM, Bal E, Sariyildiz S, Mutlu M, Akelma FK, Nalbant B, Lafci A. The prognostic value of preoperative pulmonary function tests in adolescent idiopathic scoliosis surgery. Eur Spine J. 2026 May;35(5):2362-2371. doi: 10.1007/s00586-025-09723-x. Epub 2026 Jan 7.
PubMed 41495300
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative Pulmonary Function Tests in Predicting Postoperative Intensive Care Need in Adolescent Idiopathic Scoliosis Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06756880
- Acronym / sponsor ID
- AIS
- Keywords
- Adolescent Idiopathic Scoliosis, Preoperative Pulmonary Function Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal risk | – | Diagnostic Test: Pulmonary function testz score is greater than -1.645 |
| Low risk | – | Diagnostic Test: Pulmonary function testz score between -1.645 and -2.5 |
| Medium risk | – | Diagnostic Test: Pulmonary function testz score between -2.5 and -4.0 |
| High risk | – | Diagnostic Test: Pulmonary function testz score of less than -4.0 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age range 10-18
- Patients who underwent posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis under general anesthesia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function testPulmonary function test results performed closest to the date of surgery and considered successful according to American Thoracic Society standards | Diagnostic test | High risk, Low risk, Medium risk, normal risk |
Primary outcome
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.
7 secondary outcomes
Hospital stay
Time frame: 2019 - 2024
Need for blood transfusion
Time frame: 2019 - 2024
Mortality status
Time frame: 2019 - 2024
İnotropic support requirement
Time frame: 2019 - 2024
Cobb angle
Time frame: 2019 - 2024
Location of scoliosis and number of affected vertebrae
Time frame: 2019 - 2024
Need for postoperative intubation
Time frame: 2019 - 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 41495300Erdem G, Aksoy SM, Bal E, Sariyildiz S, Mutlu M, Akelma FK, Nalbant B, Lafci A. The prognostic value of preoperative pulmonary function tests in adolescent idiopathic scoliosis surgery. Eur Spine J. 2026 May;35(5):2362-2371. doi: 10.1007/s00586-025-09723-x. Epub 2026 Jan 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Pulmonary Function Test, Preoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for intensive care admission (time frame: 2019 - 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.