OxygenNCT07487324
Oxygenation in Posterior Stabilization Surgery
An observational study of Oxygen and Oxygen Saturation, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of prone positioning on oxygenation, ventilation, and hemodynamic parameters in patients undergoing posterior stabilization surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oxygen, Oxygen Saturation
- What is being tested?
- blood gase
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 15 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study population consists of women reproductive age (18-80 years ) who are sheduled to undergo Posterior Stabilization Surgery under general anesthesia.
Who may be able to join
- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya Universt
Sakarya, Karabük Province, 78000
About this study
Official title: Factors Determining Oxygenation in Posterior Stabilization Surgery: The Role of Positioning and Mechanical Ventilation Parameters
This study aims to evaluate the effects of prone positioning on oxygenation, ventilation, and hemodynamic parameters in patients undergoing posterior stabilization surgery under general anesthesia. By comparing routine anesthesia and monitoring data obtained in the supine and prone positions, the study seeks to determine how positional changes influence respiratory mechanics and perioperative physiological stability.
Read the 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.
- Conditions
- Oxygen, Oxygen Saturation
- Being tested
- blood gase
- Keywords
- oxygenation, Posterior Stabilization Surgery, Mechanical Ventilation Parameters, optic nerve sheath diamater
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood gaseOther
Arterial blood gas samples will be obtained from patients, and alveolar oxygenation ratios will be compared between the supine and prone positions.
| Study group | Role | What they receive |
|---|---|---|
| group supine | Retrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded while patients were in the supine position before prone positioning. Receives: Other: blood gase | |
| group prone | Retrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded after patients were placed in the prone position during posterior stabilization surgery. Receives: Other: blood gase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar oxygenation between supine and prone positions
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.
Measured: within 20 minutes after anesthesia induction
Secondary outcomes (1)
Change in optic nerve sheath diameter between supine and prone positions
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.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
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 OxygenStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esragundogdu, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487324
- Sponsor's protocol ID
- SAU-ANE-EG-01
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data. Data will be collected and analyzed solely for research purposes and will remain confidential in accordance with institutional and ethical guidelines
Publications
Radstrom M, Loswick AC, Bengtsson JP. Respiratory effects of the kneeling prone position for low back surgery. Eur J Anaesthesiol. 2004 Apr;21(4):279-83. doi: 10.1017/s0265021504004053.
PubMed 15109190
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Determining Oxygenation in Posterior Stabilization Surgery: The Role of Positioning and Mechanical Ventilation Parameters
- ClinicalTrials.gov ID
- NCT07487324
- Acronym / sponsor ID
- SAU-ANE-EG-01
- Conditions
- Oxygen, Oxygen Saturation
- Keywords
- oxygenation, Posterior Stabilization Surgery, Mechanical Ventilation Parameters, optic nerve sheath diamater
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
This study aims to evaluate the effects of prone positioning on oxygenation, ventilation, and hemodynamic parameters in patients undergoing posterior stabilization surgery under general anesthesia. By comparing routine anesthesia and monitoring data obtained in the supine and prone positions, the study seeks to determine how positional changes influence respiratory mechanics and perioperative physiological stability.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group supine | – | Other: blood gaseRetrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded while patients were in the supine position before prone positioning. |
| group prone | – | Other: blood gaseRetrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded after patients were placed in the prone position during posterior stabilization surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study population consists of women reproductive age (18-80 years ) who are sheduled to undergo Posterior Stabilization Surgery under general anesthesia.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- - 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)
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 |
|---|---|---|
| blood gaseArterial blood gas samples will be obtained from patients, and alveolar oxygenation ratios will be compared between the supine and prone positions. | Other | group prone, group supine |
Primary outcome
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.
1 secondary outcome
Change in optic nerve sheath diameter between supine and prone positions
Time frame: intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Results publication: PubMed 15109190Radstrom M, Loswick AC, Bengtsson JP. Respiratory effects of the kneeling prone position for low back surgery. Eur J Anaesthesiol. 2004 Apr;21(4):279-83. doi: 10.1017/s0265021504004053.
- Individual participant dataSharing planned: No. This study will not share individual participant data. Data will be collected and analyzed solely for research purposes and will remain confidential in accordance with institutional and ethical guidelines
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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.
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 Oxygen and Oxygen Saturation, run by Sakarya University 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 1 inclusion and 11 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: opening soon, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAVVA KOCAYİĞİT, Associate Professor (905425950020, havvakocayigit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar oxygenation between supine and prone positions (time frame: within 20 minutes after anesthesia induction). 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 NCT07487324, 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 23 Mar 2026.