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Clinical Trial NCT07349719 for Lumbar Spine Stenosis, Lumbar Disc Herniation, Ventilator-Induced Lung Injury, Postoperative Complications is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Dynamic Compliance-Guided Ventilation in Lumbar Surgery 71 Randomized

Recruiting
Clinical Trial NCT07349719 is an interventional study for Lumbar Spine Stenosis, Lumbar Disc Herniation, Ventilator-Induced Lung Injury, Postoperative Complications that is recruiting. It started on January 22, 2026 with plans to enroll 71 participants. Led by Ankara City Hospital Bilkent, it is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on January 27, 2026.
Brief Summary
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 ...Show More
Official Title

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

Conditions
Lumbar Spine StenosisLumbar Disc HerniationVentilator-Induced Lung InjuryPostoperative Complications
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 1-25-1645
NCT ID Number
NCT07349719
Start Date (Actual)
2026-01-22
Last Update Posted
2026-01-27
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
71
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorDynamic Compliance Guided Ventilation
Patients receive intraoperative ventilation adjusted according to real time dynamic compliance monitoring
Dynamic Compliance Guided Ventilation
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 expirat...Show More
Active ComparatorStandart Ventilation
Patients receive intraoperative ventilation based on conventional standart settings without dynamic compliance adjustment
Standard Ventilation
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 pressu...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Modified Lung Ultrasound Score
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).
baseline, postoperative 1th hour, postoperative 24th hour
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence postoperative pulmonary complications(PPC)
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
postoperative first 7 days
Intraoperative Dynamic Compliance (Cdyn)
Mean dynamic respiratory compliance measured during the intraoperative period. Unit of Measure: mL/cmH2O
intraoperative
Intraoperative Plateau Pressure (Pplat)
Mean airway plateau pressure measured during the intraoperative period. Unit of Measure: cmH2O
intraoperative
Intraoperative Driving Pressure (ΔP)
Mean airway Driving Pressure measured during the intraoperative period. Unit of Measure: cmH2O
intraoperative
Intraoperative Peak Pressure (Ppeak)
Mean airway Peak Pressure measured during the intraoperative period. Unit of Measure: cmH2O
intraoperative
Mean arterial pressure(MAP)
Mean arterial pressure(MAP)
Baseline,intraoperative,1st hour postoperatively.
Heart Rate
Heart Rate
Baseline,intraoperative,1st hour postoperatively.
Length of stay
Hospitalization duration
From date of surgery until date of hospital discharge
Partial pressure of oxygen
arterial blood oxygen partial pressure
Baseline, intraoperative,1st hour postoperatively.
SPO2
Measurement of non invasive oxygen saturation
Baseline,intraoperative,1st hour postoperatively.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients who will undergo lumbar stabilization in the prone position

  • 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
Ankara City Hospital Bilkent logoAnkara City Hospital Bilkent
Study Responsible Party
Burak NALBANT, Principal Investigator, Assistant Professor, Ankara City Hospital Bilkent
Study Central Contact
Contact: Burak Nalbant, +905300148686, [email protected]
1 Study Locations in 1 Countries
Ankara Bilkent City Hospital, Ankara, 06800, Turkey (Türkiye)
Burak Nalbant, Contact, +905332231990, [email protected]
Recruiting