Lumbar Disc Herniation SurgeryNCT07614555
Flow-Controlled Versus Volume-Controlled Ventilation in Lumbar Disc Herniation Surgery
A study testing FCV Group and VCV Group in people with Lumbar Disc Herniation Surgery and Mechanical Ventilation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation Surgery, Mechanical Ventilation
- What is being tested?
- FCV Group and VCV Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2026to 26 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- ASA physical status I-III
- Body Mass Index between 18 and 30 kg/m²
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06170
Atakan Sezgi, M.D., 00905323327000, kansezgi@gmail.com
Jülide Ergil, Professor, 00905323469216, julideergil@hotmail.com
About this study
Official title: Comparison of Flow-Controlled and Volume-Controlled Ventilation During Lumbar Disc Herniation Surgery: A Prospective Randomized 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.
Read more
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.
- Being tested
- FCV Group, VCV Group
- Keywords
- Flow-Controlled Ventilation, Volume-Controlled Ventilation, Lumbar Disc Herniation Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCV GroupProcedure or 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 GroupProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| FCV Group | Active comparator | 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. Receives: Procedure: FCV Group |
| VCV Group | Active comparator | 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. Receives: Procedure: VCV Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes after the prone position, in the intraoperative period.
Secondary outcomes (3)
The PaO₂ measured during perioperative period
The PaO₂ values will be measured and recorded using arterial blood gas analysis.
Measured: Day 1
Peak airway pressure (Ppeak) values during perioperative period
Ppeak will be measured and recorded.
Measured: Day 1
Plateau airway pressure (Pplateau) values during perioperative period
Pplateau will be measured and recorded.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start28 May 2026
- Primary completion12 Nov 2026 (estimated)
- Study completion26 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614555
- Sponsor's protocol ID
- AEŞH-EK-2026-096
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flow-Controlled and Volume-Controlled Ventilation During Lumbar Disc Herniation Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07614555
- Acronym / sponsor ID
- AEŞH-EK-2026-096
- Keywords
- Flow-Controlled Ventilation, Volume-Controlled Ventilation, Lumbar Disc Herniation Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 28 May 2026 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 26 Nov 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCV Group | Active comparator | Procedure: FCV GroupPatients 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. |
| VCV Group | Active comparator | Procedure: VCV GroupPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- ASA physical status I-III
- Body Mass Index between 18 and 30 kg/m²
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCV GroupPatients 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 or surgery | FCV Group |
| VCV GroupPatients 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. | Procedure or surgery | VCV Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCV Group and VCV Group in people with Lumbar Disc Herniation Surgery and Mechanical Ventilation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atakan Sezgi (00905323327000, kansezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PaO₂ measured 20 minutes after prone position. (time frame: 20 minutes after the prone position, in the intraoperative period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.