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Dynamic Compliance-Guided Ventilation in Lumbar Surgery

A

Ankara City Hospital

Status

Enrolling

Conditions

Postoperative Complications
Lumbar Spine Stenosis
Ventilator-Induced Lung Injury
Lumbar Disc Herniation

Treatments

Procedure: Dynamic Compliance Guided Ventilation
Procedure: Standard Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT07349719
1-25-1645

Details and patient eligibility

About

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.

Enrollment

71 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

71 participants in 2 patient groups

Dynamic Compliance Guided Ventilation
Active Comparator group
Description:
Patients receive intraoperative ventilation adjusted according to real time dynamic compliance monitoring
Treatment:
Procedure: Dynamic Compliance Guided Ventilation
Standart Ventilation
Active Comparator group
Description:
Patients receive intraoperative ventilation based on conventional standart settings without dynamic compliance adjustment
Treatment:
Procedure: Standard Ventilation

Trial contacts and locations

1

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Central trial contact

Burak Nalbant

Data sourced from clinicaltrials.gov

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