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NCT Number: NCT07614555

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

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.

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Key information

Conditions

Lumbar Disc Herniation Surgery Mechanical Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FCV Group

Procedure

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

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 outcomes

  1. The PaO₂ measured 20 minutes after prone position.

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

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

Secondary outcomes

  1. The PaO₂ measured during perioperative period

    Time frame: Day 1

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

  2. Peak airway pressure (Ppeak) values during perioperative period

    Time frame: Day 1

    Ppeak will be measured and recorded.

  3. Plateau airway pressure (Pplateau) values during perioperative period

    Time frame: Day 1

    Pplateau will be measured and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Atakan Sezgi

CONTACT

[email protected]

00905323327000

Musa Zengin

CONTACT

[email protected]

00905307716235

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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