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NCT Number: NCT07388719

Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP 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.

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Key information

Conditions

Obesity Body Weight Mechanical Ventilation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postoperative Pulmonary Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard PEEP

Device

Application of a fixed positive end-expiratory pressure of 5 cmH₂O during intraoperative mechanical ventilation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Peak Airway Pressure

    Time frame: From induction of anesthesia until the end of surgery

    Peak inspiratory airway pressure (cmH₂O) measured intraoperatively using ventilator monitoring.

  4. Plateau Airway Pressure

    Time frame: From induction of anesthesia until the end of surgery

    Plateau airway pressure (cmH₂O) measured intraoperatively during mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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