- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487324
Oxygenation in Posterior Stabilization Surgery
Factors Determining Oxygenation in Posterior Stabilization Surgery: The Role of Positioning and Mechanical Ventilation Parameters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prone position is frequently used during posterior stabilization surgery, yet it is associated with important physiological changes that may affect both respiratory and hemodynamic function under general anesthesia. Previous studies have shown that prone positioning may improve ventilation-perfusion matching, increase functional residual capacity, and enhance oxygenation. At the same time, position-related alterations in thoracic mechanics, airway pressures, venous return, and cardiovascular parameters may influence intraoperative management.
This study is designed to comprehensively assess the physiological effects of prone positioning in anesthetized patients undergoing posterior stabilization surgery. Routine anesthesia and monitoring data collected during mechanical ventilation will be analyzed and compared between the supine and prone positions. Particular focus will be placed on oxygenation, ventilation variables, respiratory mechanics, and hemodynamic parameters in order to evaluate the impact of positional change.
In addition, the study aims to identify which clinical and monitoring findings should be prioritized during anesthetic management of patients in the prone position. By clarifying the relationship between positioning and perioperative physiological responses, the study seeks to contribute to safer anesthetic practice and to support the maintenance of adequate oxygenation and hemodynamic stability throughout surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: HAVVA KOCAYİĞİT, Associate Professor
- Phone Number: 905425950020
- Email: havvakocayigit@gmail.com
Study Locations
-
-
Karabük Province
-
Sakarya, Karabük Province, Turkey (Türkiye), 78000
- Sakarya Universt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 18 to 75 years Patients classified as ASA physical status I, II, or III according to the American Society of Anesthesiologists Patients undergoing posterior stabilization surgery Patients who voluntarily agreed to participate in the study Patients with a body mass index (BMI) <35 kg/m² Patients followed with a standard mechanical ventilation procedure
Exclusion Criteria:
- - ASA 4 olarak değerlendirilenler
- Anestezik ajan alerjisi olanlar
- Kanama diatezi bozukluğu olanlar
- Cerrahi süresi 3 saatin üstünde olanlar
- Bilinen ileri akciğer hastalığı olanlar (intertisyel akciğer hastalığı, ileri düzey KOAH, ileri düzey astım vb)
- VKI≥35 olanlar
- Obstrüktif uyku apne sendromu tanısı olanlar
- Toraks deformitesi olanlar
- Ciddi kalp yetmezliği öyküsü olanlar (EF<30)
- Şiddetli anemi öyküsü olanlar (Hg<8 mg/dl)
- Cerrahi operasyon sırasında kan transfüzyonu ihtiyacı olan hastalar
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group supine
Retrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded while patients were in the supine position before prone positioning.
|
Arterial blood gas samples will be obtained from patients, and alveolar oxygenation ratios will be compared between the supine and prone positions.
|
|
group prone
Retrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded after patients were placed in the prone position during posterior stabilization surgery.
|
Arterial blood gas samples will be obtained from patients, and alveolar oxygenation ratios will be compared between the supine and prone positions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in alveolar oxygenation between supine and prone positions
Time Frame: within 20 minutes after anesthesia induction
|
The primary outcome of this study is to evaluate the difference in alveolar oxygenation between the supine and prone positions in patients undergoing posterior stabilization surgery.
Arterial blood gas samples obtained during surgery will be used to compare oxygenation parameters measured in both positions and to assess the effect of positional change on oxygenation.
|
within 20 minutes after anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in optic nerve sheath diameter between supine and prone positions
Time Frame: intraoperatively
|
The secondary outcome is the comparison of optic nerve sheath diameter measurements obtained in the supine position and after positioning the patient prone during posterior stabilization surgery.
This assessment is intended to evaluate the effect of positional change on optic nerve sheath diameter.
|
intraoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAU-ANE-EG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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