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NCT Number: NCT07545733

Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery

This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.

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Key information

About this study

Prone positioning during lumbar spine surgery is associated with increased intrathoracic pressure, reduced lung compliance, and impaired ventilation-perfusion matching, which may negatively affect respiratory mechanics and gas exchange. Mechanical ventilation strategies, particularly the application of positive end-expiratory pressure (PEEP), play a critical role in preventing atelectasis and optimizing oxygenation.

Pressure-controlled ventilation with volume guarantee (PCV-VG) is a modern ventilation mode that ensures target tidal volume delivery while minimizing airway pressures, thereby reducing the risk of ventilator-induced lung injury. In recent years, driving pressure (ΔP) and mechanical power have emerged as important parameters reflecting lung stress and injury during mechanical ventilation.

This prospective randomized controlled trial aims to evaluate the effects of two different PEEP levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics and gas exchange in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Patients will be randomly assigned into two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP. Ventilation will be standardized using PCV-VG mode with a tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.

Hemodynamic parameters and respiratory variables, including peak airway pressure, plateau pressure, dynamic compliance, airway resistance, tidal volume, and end-tidal CO₂, will be recorded at predefined time points. Arterial blood gas analyses will be performed at selected intervals to assess gas exchange.

The primary outcome of the study is driving pressure (ΔP), while secondary outcomes include mechanical power, oxygenation parameters, PaCO₂-EtCO₂ gradient, and physiologic dead space fraction (VD/VT).

The findings of this study are expected to provide clinical evidence regarding the optimal PEEP level in prone lumbar surgery and contribute to improving intraoperative lung-protective ventilation strategies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective lumbar spine surgery in the prone position
  • Planned general anesthesia with total intravenous anesthesia (TIVA)
  • Ability to provide informed consent

Exclusion criteria

  • Body mass index (BMI) ≥ 30 kg/m²
  • History of significant pulmonary disease (e.g., COPD, asthma)
  • Severe cardiovascular disease
  • Pregnancy
  • Known difficult airway
  • Requirement for intraoperative vasopressor infusion due to hemodynamic instability
  • Conversion to different surgical position or change in surgical plan
  • Incomplete data or protocol deviation

Treatment and study plan

Mechanical Ventilation (PEEP)

Device

Mechanical ventilation will be applied using pressure-controlled ventilation with volume guarantee (PCV-VG) mode during prone lumbar surgery under total intravenous anesthesia (TIVA). Two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) will be used according to group allocation. Tidal volume will be set at 6-8 mL/kg predicted body weight, and respiratory rate will be adjusted to maintain normocapnia (EtCO₂ 35-40 mmHg).

Other names: PCV-VG Ventilation, Lung Protective Ventilation

Primary outcomes

  1. Driving Pressure (ΔP)

    Time frame: Intraoperative period (at predefined time points: T0, T2, T5)

    Driving pressure (ΔP), calculated as the difference between plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), will be used as the primary outcome to assess lung stress during mechanical ventilation.

Secondary outcomes

  1. Mechanical Power

    Time frame: Intraoperative period (T0, T2, T5)

    Mechanical power will be calculated to quantify the energy delivered to the respiratory system during mechanical ventilation.

  2. Oxygenation (PaO₂/FiO₂ Ratio)

    Time frame: Intraoperative period (T0, T2, T5)

    Oxygenation status will be assessed using the arterial oxygen partial pressure to inspired oxygen fraction (PaO₂/FiO₂) ratio.

  3. PaCO₂-EtCO₂ Gradient

    Time frame: Intraoperative period (T0, T2, T5)

    The difference between arterial carbon dioxide pressure (PaCO₂) and end-tidal CO₂ (EtCO₂) will be used to evaluate ventilation-perfusion mismatch.

  4. Physiological Dead Space Fraction (VD/VT)

    Time frame: Intraoperative period (T0, T2, T5)

    Physiological dead space fraction will be calculated using the Bohr equation to assess ventilation efficiency.

  5. Dynamic Lung Compliance (Cdyn)

    Time frame: Intraoperative period (all time points)

    Dynamic compliance will be recorded to evaluate changes in lung mechanics during ventilation.

  6. Peak Airway Pressure (Ppeak)

    Time frame: Intraoperative period (all time points)

    Peak airway pressure will be recorded to assess airway pressure changes during mechanical ventilation.

Study contacts

Contact information is provided by the study sponsor or research team.

Basak Pehlivan, Assoc Prof

CONTACT

[email protected]

5054083199

Veli F Pehlivan, MD

CONTACT

[email protected]

5327696566

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

The Effect of Different PEEP Levels Accompanied by PCV-VG Mode on Respiratory Mechanics and Gas Exchange in Lumbar Surgeries Performed in the Prone Position Under TIVA

Acronym: PROPEEP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 29, 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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