ClinicalTrials.Veeva

Menu

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

A

Ankara Etlik City Hospital

Status

Enrolling

Conditions

Lumbar Disc Herniation Surgery
Mechanical Ventilation

Treatments

Procedure: FCV Group
Procedure: VCV Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07614555
AEŞH-EK-2026-096

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

FCV Group
Active Comparator group
Description:
Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. %50 FiO₂ will be applied, and a driving pressure of 12 cmH₂O will be used. After intubation, the patient will be placed in the prone position. Following the prone position, the patient's FiO₂ will be maintained between 0.8 and 1.0 for 20 minutes. After the 20th minute, ventilator settings will be returned to the baseline values. Tidal volume will be generated and recorded by the ventilator according to the driving pressure and the patient's lung mechanics. Minute ventilation will be adjusted based on the target tidal volume. The target tidal volume will be set at 6-8 mL/kg (7 mL/kg) with a respiratory rate of 12 breaths/min. Positive end-expiratory pressure (PEEP) will be maintained at 5 cmH₂O. The respiratory rate will be further titrated to maintain ETCO₂ between 35 and 40 mmHg.
Treatment:
Procedure: FCV Group
VCV Group
Active Comparator group
Description:
Patients allocated to the VCV group will receive intraoperative mechanical ventilation using a conventional volume-controlled ventilation mode throughout surgery under general anesthesia. Anesthetic induction, monitoring, and perioperative management will follow the same standardized clinical protocols as those used in the FCV group. Ventilatory parameters, including peak and plateau airway pressures and arterial blood gas measurements, will be collected at identical predefined intraoperative time points. This group serves as the comparator arm for evaluating the effects of volume-controlled ventilation on airway pressures and oxygenation in these patients.
Treatment:
Procedure: VCV Group

Trial contacts and locations

1

Loading...

Central trial contact

Musa Zengin; Atakan Sezgi

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems