- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388719
Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP in Obese Patients Undergoing Spinal Surgery
A Prospective Interventional Study Comparing Standard and Dynamic Compliance-Guided Individualized Positive End-Expiratory Pressure on Intraoperative Oxygenation and Postoperative Pulmonary Complications in Obese Patients Undergoing Spinal Surgery
This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.
Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.
The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey (Türkiye), 42090
- Konya City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- Scheduled for elective spinal surgery under general anesthesia
- Requirement for intraoperative mechanical ventilation
- American Society of Anesthesiologists (ASA) physical status II-III
- Provision of written informed consent
Exclusion Criteria:
- Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
- Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
- History of thoracic surgery affecting lung mechanics
- Pregnancy
- Emergency surgery
- Intraoperative need for deviation from the planned ventilation protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard PEEP
Patients assigned to this arm receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the intraoperative period during mechanical ventilation.
|
Application of a fixed positive end-expiratory pressure of 5 cmH₂O during intraoperative mechanical ventilation.
|
|
Experimental: Dynamic Compliance-Guided Individualized PEEP
Patients assigned to this arm receive individualized positive end-expiratory pressure (PEEP) titrated according to intraoperative dynamic lung compliance, with the aim of optimizing respiratory mechanics while avoiding overdistension.
|
Application of a fixed positive end-expiratory pressure of 5 cmH₂O during intraoperative mechanical ventilation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
Time Frame: From induction of anesthesia until the end of surgery
|
The primary outcome is intraoperative oxygenation assessed by the arterial partial pressure of oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratio during mechanical ventilation.
|
From induction of anesthesia until the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Lung Compliance
Time Frame: From induction of anesthesia until the end of surgery
|
Dynamic lung compliance (mL/cmH₂O) measured intraoperatively via ventilator respiratory mechanics monitoring.
|
From induction of anesthesia until the end of surgery
|
|
Static Lung Compliance
Time Frame: From induction of anesthesia until the end of surgery
|
Static lung compliance (mL/cmH₂O) measured intraoperatively via ventilator plateau pressure analysis.
|
From induction of anesthesia until the end of surgery
|
|
Peak Airway Pressure
Time Frame: From induction of anesthesia until the end of surgery
|
Peak inspiratory airway pressure (cmH₂O) measured intraoperatively using ventilator monitoring.
|
From induction of anesthesia until the end of surgery
|
|
Plateau Airway Pressure
Time Frame: From induction of anesthesia until the end of surgery
|
Plateau airway pressure (cmH₂O) measured intraoperatively during mechanical ventilation.
|
From induction of anesthesia until the end of surgery
|
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
- NEU-2024-5206
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
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