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Recruiting NCT07614555

Flow-Controlled Versus Volume-Controlled Ventilation in Lumbar Disc Herniation Surgery

No phase Interventional Lumbar Disc Herniation Surgery Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FCV Group, VCV Group.
Who it may be relevant to
Registry conditions: Lumbar Disc Herniation Surgery, Mechanical Ventilation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Flow-Controlled and Volume-Controlled Ventilation During Lumbar Disc Herniation Surgery: A Prospective Randomized Trial

Overview

This prospective randomized trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on intraoperative airway pressures and oxygenation in patients undergoing lumbar disc herniation surgery under general anesthesia. Adult patients aged 18-65 years, with ASA physical status I-III and a body mass index of 18-30 kg/m², will be allocated to receive either FCV or VCV during routine intraoperative mechanical ventilation. Ventilatory parameters, including peak airway pressure, plateau pressure, pulmonary compliance, EtCO₂, SpO₂, and arterial blood gas variables, will be recorded at predefined time points after intubation. The primary endpoint is the PaO₂ value measured after 20 minutes in the prone position. By comparing respiratory mechanics and oxygenation between the two ventilation modes, this study aims to contribute to the optimization of intraoperative ventilatory management in lumbar disc herniation surgery.

Interventions

  • Procedure FCV Group
    Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. Patients will be started on ventilation after intubation with 50% oxygen, driving pressure 12, PEEP 5, and a 1:1 inspiration/expiratory ratio.
  • Procedure VCV Group
    Patients allocated to the VCV group will receive intraoperative mechanical ventilation using a conventional volume-controlled ventilation mode throughout surgery under general anesthesia. Patients will be started on ventilation after intubation with 50% oxygen, 7 ml/ideal body weight tidal volume, PEEP 5, 12 breaths per minute frequency, and a 1:2 inspiration/expiration ratio.

Primary outcome measures

  • The PaO₂ measured 20 minutes after prone position. [Time frame: 20 minutes after the prone position, in the intraoperative period.]
Secondary outcome measures (3)
  • The PaO₂ measured during perioperative period [Time frame: Day 1]
  • Peak airway pressure (Ppeak) values during perioperative period [Time frame: Day 1]
  • Plateau airway pressure (Pplateau) values during perioperative period [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years
  • ASA physical status I-III
  • Body Mass Index between 18 and 30 kg/m²

Exclusion criteria

  • Age < 18 years or > 65 years
  • Known or previously diagnosed pulmonary disease
  • Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ < 50% predicted, severe restrictive or obstructive pathology)
  • Patients with markedly altered lung anatomy or function due to prior major thoracic surgery
  • Patients who were dependent on supplemental oxygen therapy in the preoperative period
  • ASA physical status IV or higher
  • Refusal or inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07614555 · AEŞH-EK-2026-096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗