Health TrialsbyHealthPanel

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

ConditionsLumbar Disc Herniation SurgeryMechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

ASA physical status I-III

Body Mass Index between 18 and 30 kg/m²

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FCV Group

    Procedure/Surgery

    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.

  • VCV Group

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: FCV GroupActive comparator 1 intervention
Group B: VCV GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The PaO₂ measured 20 minutes after prone position.

The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after the prone position.

Time frame
20 minutes after the prone position, in the intraoperative period.

Secondary outcomes

1

The PaO₂ measured during perioperative period

The PaO₂ values will be measured and recorded using arterial blood gas analysis.

Time frame
Day 1
2

Peak airway pressure (Ppeak) values during perioperative period

Ppeak will be measured and recorded.

Time frame
Day 1
3

Plateau airway pressure (Pplateau) values during perioperative period

Pplateau will be measured and recorded.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Etlik City Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now