Lumbar Disc HerniationPROPEEPNCT07545733
Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery
A study testing Mechanical Ventilation (PEEP) in people with Lumbar Disc Herniation and Spinal Surgery, run by Harran University.
Trial summary
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Spinal Surgery, Prone Position
- What is being tested?
- Mechanical Ventilation (PEEP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 3 Oct 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
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective lumbar spine surgery in the prone position
- Planned general anesthesia with total intravenous anesthesia (TIVA)
- Ability to provide informed consent
Who cannot join
- Body mass index (BMI) ≥ 30 kg/m²
- History of significant pulmonary disease (e.g., COPD, asthma)
- Severe cardiovascular disease
- Pregnancy
- Known difficult airway
- Requirement for intraoperative vasopressor infusion due to hemodynamic instability
- Conversion to different surgical position or change in surgical plan
- Incomplete data or protocol deviation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Different PEEP Levels Accompanied by PCV-VG Mode on Respiratory Mechanics and Gas Exchange in Lumbar Surgeries Performed in the Prone Position Under TIVA
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
Read the detailed description
Prone positioning during lumbar spine surgery is associated with increased intrathoracic pressure, reduced lung compliance, and impaired ventilation-perfusion matching, which may negatively affect respiratory mechanics and gas exchange. Mechanical ventilation strategies, particularly the application of positive end-expiratory pressure (PEEP), play a critical role in preventing atelectasis and optimizing oxygenation.
Pressure-controlled ventilation with volume guarantee (PCV-VG) is a modern ventilation mode that ensures target tidal volume delivery while minimizing airway pressures, thereby reducing the risk of ventilator-induced lung injury. In recent years, driving pressure (ΔP) and mechanical power have emerged as important parameters reflecting lung stress and injury during mechanical ventilation.
This prospective randomized controlled trial aims to evaluate the effects of two different PEEP levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics and gas exchange in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Patients will be randomly assigned into two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP. Ventilation will be standardized using PCV-VG mode with a tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.
Hemodynamic parameters and respiratory variables, including peak airway pressure, plateau pressure, dynamic compliance, airway resistance, tidal volume, and end-tidal CO₂, will be recorded at predefined time points. Arterial blood gas analyses will be performed at selected intervals to assess gas exchange.
The primary outcome of the study is driving pressure (ΔP), while secondary outcomes include mechanical power, oxygenation parameters, PaCO₂-EtCO₂ gradient, and physiologic dead space fraction (VD/VT).
The findings of this study are expected to provide clinical evidence regarding the optimal PEEP level in prone lumbar surgery and contribute to improving intraoperative lung-protective ventilation strategies.
- Being tested
- Mechanical Ventilation (PEEP)
- Keywords
- PEEP, Driving Pressure, Mechanical Power, PCV-VG Ventilation, Prone Position, Lung Protective Ventilation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Ventilation (PEEP)Device
Also called PCV-VG Ventilation, Lung Protective Ventilation
Mechanical ventilation will be applied using pressure-controlled ventilation with volume guarantee (PCV-VG) mode during prone lumbar surgery under total intravenous anesthesia (TIVA). Two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) will be used according to group allocation. Tidal volume will be set at 6-8 mL/kg predicted body weight, and respiratory rate will be adjusted to maintain normocapnia (EtCO₂ 35-40 mmHg).
| Study group | Role | What they receive |
|---|---|---|
| PEEP-5 Group | Experimental | Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 5 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia. Receives: Device: Mechanical Ventilation (PEEP) |
| PEEP-8 Group | Experimental | Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 8 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia. Receives: Device: Mechanical Ventilation (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Pressure (ΔP)
Driving pressure (ΔP), calculated as the difference between plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), will be used as the primary outcome to assess lung stress during mechanical ventilation.
Measured: Intraoperative period (at predefined time points: T0, T2, T5)
Secondary outcomes (6)
Mechanical Power
Mechanical power will be calculated to quantify the energy delivered to the respiratory system during mechanical ventilation.
Measured: Intraoperative period (T0, T2, T5)
Oxygenation (PaO₂/FiO₂ Ratio)
Oxygenation status will be assessed using the arterial oxygen partial pressure to inspired oxygen fraction (PaO₂/FiO₂) ratio.
Measured: Intraoperative period (T0, T2, T5)
PaCO₂-EtCO₂ Gradient
The difference between arterial carbon dioxide pressure (PaCO₂) and end-tidal CO₂ (EtCO₂) will be used to evaluate ventilation-perfusion mismatch.
Measured: Intraoperative period (T0, T2, T5)
Physiological Dead Space Fraction (VD/VT)
Physiological dead space fraction will be calculated using the Bohr equation to assess ventilation efficiency.
Measured: Intraoperative period (T0, T2, T5)
Dynamic Lung Compliance (Cdyn)
Dynamic compliance will be recorded to evaluate changes in lung mechanics during ventilation.
Measured: Intraoperative period (all time points)
Peak Airway Pressure (Ppeak)
Peak airway pressure will be recorded to assess airway pressure changes during mechanical ventilation.
Measured: Intraoperative period (all time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Aug 2026 (estimated)
- Primary completion2 Sep 2026 (estimated)
- Study completion3 Oct 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 HerniationStudies 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
- Model description
- Participants will be randomly assigned to one of two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP during mechanical ventilation in prone lumbar surgery.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
- Investigators
- Basak Pehlivan, Asoc Prof, Principal investigator, Harran University Faculty of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545733
- Sponsor's protocol ID
- REŞIT-PEEP-2026
- Acronym
- PROPEEP
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different PEEP Levels Accompanied by PCV-VG Mode on Respiratory Mechanics and Gas Exchange in Lumbar Surgeries Performed in the Prone Position Under TIVA
- ClinicalTrials.gov ID
- NCT07545733
- Acronym / sponsor ID
- PROPEEP / REŞIT-PEEP-2026
- Keywords
- PEEP, Driving Pressure, Mechanical Power, PCV-VG Ventilation, Prone Position, Lung Protective Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 3 Oct 2026 (estimated)
- First posted
- 22 Apr 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 randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
Detailed description
Prone positioning during lumbar spine surgery is associated with increased intrathoracic pressure, reduced lung compliance, and impaired ventilation-perfusion matching, which may negatively affect respiratory mechanics and gas exchange. Mechanical ventilation strategies, particularly the application of positive end-expiratory pressure (PEEP), play a critical role in preventing atelectasis and optimizing oxygenation.
Pressure-controlled ventilation with volume guarantee (PCV-VG) is a modern ventilation mode that ensures target tidal volume delivery while minimizing airway pressures, thereby reducing the risk of ventilator-induced lung injury. In recent years, driving pressure (ΔP) and mechanical power have emerged as important parameters reflecting lung stress and injury during mechanical ventilation.
This prospective randomized controlled trial aims to evaluate the effects of two different PEEP levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics and gas exchange in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Patients will be randomly assigned into two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP. Ventilation will be standardized using PCV-VG mode with a tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.
Hemodynamic parameters and respiratory variables, including peak airway pressure, plateau pressure, dynamic compliance, airway resistance, tidal volume, and end-tidal CO₂, will be recorded at predefined time points. Arterial blood gas analyses will be performed at selected intervals to assess gas exchange.
The primary outcome of the study is driving pressure (ΔP), while secondary outcomes include mechanical power, oxygenation parameters, PaCO₂-EtCO₂ gradient, and physiologic dead space fraction (VD/VT).
The findings of this study are expected to provide clinical evidence regarding the optimal PEEP level in prone lumbar surgery and contribute to improving intraoperative lung-protective ventilation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP during mechanical ventilation in prone lumbar surgery.
| Arm | Type | Receives |
|---|---|---|
| PEEP-5 Group | Experimental | Device: Mechanical Ventilation (PEEP)Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 5 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia. |
| PEEP-8 Group | Experimental | Device: Mechanical Ventilation (PEEP)Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 8 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective lumbar spine surgery in the prone position
- Planned general anesthesia with total intravenous anesthesia (TIVA)
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Body mass index (BMI) ≥ 30 kg/m²
- History of significant pulmonary disease (e.g., COPD, asthma)
- Severe cardiovascular disease
- Pregnancy
- Known difficult airway
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 |
|---|---|---|
| Mechanical Ventilation (PEEP)Also: PCV-VG Ventilation, Lung Protective VentilationMechanical ventilation will be applied using pressure-controlled ventilation with volume guarantee (PCV-VG) mode during prone lumbar surgery under total intravenous anesthesia (TIVA). Two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) will be used according to group allocation. Tidal volume will be set at 6-8 mL/kg predicted body weight, and respiratory rate will be adjusted to maintain normocapnia (EtCO₂ 35-40 mmHg). | Device | PEEP-5 Group, PEEP-8 Group |
Primary outcome
Driving Pressure (ΔP)
Time frame: Intraoperative period (at predefined time points: T0, T2, T5)
Driving pressure (ΔP), calculated as the difference between plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), will be used as the primary outcome to assess lung stress during mechanical ventilation.
6 secondary outcomes
Mechanical Power
Time frame: Intraoperative period (T0, T2, T5)
Oxygenation (PaO₂/FiO₂ Ratio)
Time frame: Intraoperative period (T0, T2, T5)
PaCO₂-EtCO₂ Gradient
Time frame: Intraoperative period (T0, T2, T5)
Physiological Dead Space Fraction (VD/VT)
Time frame: Intraoperative period (T0, T2, T5)
Dynamic Lung Compliance (Cdyn)
Time frame: Intraoperative period (all time points)
Peak Airway Pressure (Ppeak)
Time frame: Intraoperative period (all time points)
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Basak Pehlivan, Asoc Prof principal investigator
Harran University Faculty of Medicine, Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation (PEEP) in people with Lumbar Disc Herniation and Spinal Surgery, run by Harran University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Basak Pehlivan, Assoc Prof (5054083199, bpehlivan@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Pressure (ΔP) (time frame: Intraoperative period (at predefined time points: T0, T2, T5)). 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 11 Aug 2026.