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Clinical Trials/NCT07545733
NCT07545733Not yet recruitingNot Applicable

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

Harran University0 sites60 target enrollmentStarted: August 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Driving Pressure (ΔP)

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

This is an open-label study. Due to the nature of the intervention (ventilator settings), masking of care providers and investigators is not feasible.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

PEEP-5 Group

Experimental

Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 5 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.

Intervention: Mechanical Ventilation (PEEP) (Device)

PEEP-8 Group

Experimental

Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 8 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.

Intervention: Mechanical Ventilation (PEEP) (Device)

Outcomes

Primary Outcomes

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

  • Mechanical Power(Intraoperative period (T0, T2, T5))
  • Oxygenation (PaO₂/FiO₂ Ratio)(Intraoperative period (T0, T2, T5))
  • PaCO₂-EtCO₂ Gradient(Intraoperative period (T0, T2, T5))
  • Physiological Dead Space Fraction (VD/VT)(Intraoperative period (T0, T2, T5))
  • Dynamic Lung Compliance (Cdyn)(Intraoperative period (all time points))
  • Peak Airway Pressure (Ppeak)(Intraoperative period (all time points))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Veli Fahri Pehlivan

Assistant Professor

Harran University

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