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NCT Number: NCT07349719

Dynamic Compliance-Guided Ventilation in Lumbar Surgery

Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Dynamic compliance-guided ventilation provides a real-time, individualized approach by adjusting ventilatory parameters according to lung compliance.

This prospective randomized controlled study aims to evaluate the effects of dynamic compliance-guided ventilation compared with standard ventilation strategies on postoperative pulmonary function in patients undergoing lumbar stabilization surgery. Eligible patients will be randomly assigned to either the compliance-guided group or the conventional ventilation group.

In this study, the investigators aim to prospectively compare ventilation with the dynamic compliance (Cdyn) approach-one of the lung-protective ventilation strategies-with conventional ventilation methods in patients undergoing surgery in the prone position. The primary outcome will be evaluated using a modified lung ultrasound scoring system based on the most severely affected regions of aeration loss. Secondary objectives include the assessment of intraoperative hemodynamics, respiratory mechanics, and the effects on postoperative pulmonary function.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who will undergo lumbar stabilization in the prone position

Exclusion criteria

  • Patients with ASA classification IV or higher
  • Patients with obesity (BMI>30) or cachexia (BMI<18)
  • Allergy to standard medications used during general anesthesia
  • Contraindications to PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right heart failure)
  • Previous lung surgery (any)
  • Known serious heart disease defined as New York Heart Association class III or higher
  • Patients with severe asthma and COPD
  • Acute myocardial infarction within the last 12 months before surgery
  • Neuromuscular disease

Treatment and study plan

Dynamic Compliance Guided Ventilation

Procedure

After intubation and prone positioning, both groups will undergo the same initial recruitment maneuver as described above. In the dynamic compliance-guided group, positive end expiratory pressure(PEEP) will then be titrated according to dynamic compliance (Cdyn = VT / [Ppeak - PEEP])(Ppeak: Peak airway pressure)(VT:Tidal volume). Tidal volume will be set at 7 ml/kg, respiratory rate 12/min, and positive end expiratory pressure(PEEP) reduced stepwise from 20 cmH₂O to 5 cmH₂O in increments of 2 cmH₂O. Each positive end expiratory pressure(PEEP) level (19, 17, 15, 13, 11, 9, 7, 5 cmH₂O) will be maintained for 10 respiratory cycles, with Cdyn measured at the end of each level. The positive end expiratory pressure(PEEP) corresponding to the highest dynamic compliance will be selected and maintained throughout the surgery.In both groups, a 30% t-pause will be applied throughout the operation after intubation. Patients will be ventilated in volume-controlled ventilation (VCV) mode.

Standard ventilation

Procedure

After intubation, both groups will initially receive conventional ventilation in volume-controlled mode with a tidal volume of 7 ml/kg (predicted body weight), positive end expiratory pressure(PEEP) of 5 cmH₂O, and an inspiratory-to-expiratory ratio of 1:2. Respiratory rate will be adjusted to maintain end-tidal CO₂ between 35-45 mmHg. Following prone positioning, a recruitment maneuver will be performed using pressure-controlled ventilation, gradually increasing positive end expiratory pressure(PEEP) from 5 to 20 cmH₂O and holding for 20 seconds. After recruitment, the standard ventilation group will continue with the initial ventilator settings until the end of the surgery. Patients will be ventilated in volume-controlled ventilation (VCV) mode.

Primary outcomes

  1. Modified Lung Ultrasound Score

    Time frame: baseline, postoperative 1th hour, postoperative 24th hour

    The assessment will be performed using the Modified Lung Ultrasound Scoring system. The scale ranges from a minimum of 0 to a maximum of 36 points. A score of 0 indicates normal aeration in all zones, while a score of 36 represents the worst possible aeration loss. Higher scores indicate a worse outcome (increased lung aeration loss/atelectasis).

Secondary outcomes

  1. Incidence postoperative pulmonary complications(PPC)

    Time frame: postoperative first 7 days

    Number of participants with at least one postoperative pulmonary complication (including atelectasis, pneumonia, bronchospasm, hypoxemia, or reintubation) within the first 7 days after surgery.

    Percentage of participants

  2. Intraoperative Dynamic Compliance (Cdyn)

    Time frame: intraoperative

    Mean dynamic respiratory compliance measured during the intraoperative period. Unit of Measure: mL/cmH2O

  3. Intraoperative Plateau Pressure (Pplat)

    Time frame: intraoperative

    Mean airway plateau pressure measured during the intraoperative period. Unit of Measure: cmH2O

  4. Intraoperative Driving Pressure (ΔP)

    Time frame: intraoperative

    Mean airway Driving Pressure measured during the intraoperative period. Unit of Measure: cmH2O

  5. Intraoperative Peak Pressure (Ppeak)

    Time frame: intraoperative

    Mean airway Peak Pressure measured during the intraoperative period. Unit of Measure: cmH2O

  6. Mean arterial pressure(MAP)

    Time frame: Baseline,intraoperative,1st hour postoperatively.

    Mean arterial pressure(MAP)

  7. Heart Rate

    Time frame: Baseline,intraoperative,1st hour postoperatively.

    Heart Rate

  8. Length of stay

    Time frame: From date of surgery until date of hospital discharge

    Hospitalization duration

  9. Partial pressure of oxygen

    Time frame: Baseline, intraoperative,1st hour postoperatively.

    arterial blood oxygen partial pressure

  10. SPO2

    Time frame: Baseline,intraoperative,1st hour postoperatively.

    Measurement of non invasive oxygen saturation

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Impact of Dynamic Compliance-guided Ventilation on Postoperative Pulmonary Function in Lumbar Stabilization Surgery:A Prospective Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jun 9, 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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