NCT07487324

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

oxygenationPosterior Stabilization SurgeryMechanical Ventilation Parametersoptic nerve sheath diamater

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 20 minutes after anesthesia induction

Secondary Outcomes (1)

  • Change in optic nerve sheath diameter between supine and prone positions

    intraoperatively

Study Arms (2)

group supine

Retrospective evaluation of routine intraoperative anesthesia and monitoring parameters recorded while patients were in the supine position before prone positioning.

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.

Other: blood gase

Interventions

Arterial blood gas samples will be obtained from patients, and alveolar oxygenation ratios will be compared between the supine and prone positions.

group pronegroup supine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study population consists of women reproductive age (18-80 years ) who are sheduled to undergo Posterior Stabilization Surgery under general anesthesia.

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Universt

Sakarya, Karabük Province, 78000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Central Study Contacts

HAVVA KOCAYİĞİT, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ANESTHESIOLOGIST

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations