AzTrials
AzTrials

Lumbar Spine StenosisNCT07349719

Dynamic Compliance-Guided Ventilation in Lumbar Surgery

A study testing Dynamic Compliance Guided Ventilation and Standard Ventilation in people with Lumbar Spine Stenosis and Lumbar Disc Herniation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Dynamic Compliance Guided Ventilation and Standard Ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jan 2026to 1 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who will undergo lumbar stabilization in the prone position

Who cannot join

  • Patients with ASA classification IV or higher
  • Patients with obesity (BMI>30) or cachexia (BMI<18)
  • Allergy to standard medications used during general anesthesia
  • Contraindications to PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right heart failure)
  • Previous lung surgery (any)
  • Known serious heart disease defined as New York Heart Association class III or higher
Show all 9Show fewer
  • Patients with severe asthma and COPD
  • Acute myocardial infarction within the last 12 months before surgery
  • Neuromuscular disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Bilkent City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Dynamic Compliance-guided Ventilation on Postoperative Pulmonary Function in Lumbar Stabilization Surgery:A Prospective Study

Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Dynamic compliance-guided ventilation provides a real-time, individualized approach by adjusting ventilatory parameters according to lung compliance.

This prospective randomized controlled study aims to evaluate the effects of dynamic compliance-guided ventilation compared with standard ventilation strategies on postoperative pulmonary function in patients undergoing lumbar stabilization surgery. Eligible patients will be randomly assigned to either the compliance-guided group or the conventional ventilation group.

In this study, the investigators aim to prospectively compare ventilation with the dynamic compliance (Cdyn) approach-one of the lung-protective ventilation strategies-with conventional ventilation methods in patients undergoing surgery in the prone position. The primary outcome will be evaluated using a modified lung ultrasound scoring system based on the most severely affected regions of aeration loss. Secondary objectives include the assessment of intraoperative hemodynamics, respiratory mechanics, and the effects on postoperative pulmonary function.

Being tested
Dynamic Compliance Guided Ventilation, Standard Ventilation
Medical subject headings
Intervertebral Disc Displacement, Ventilator-Induced Lung Injury, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Compliance Guided VentilationProcedure or surgery

    After intubation and prone positioning, both groups will undergo the same initial recruitment maneuver as described above. In the dynamic compliance-guided group, positive end expiratory pressure(PEEP) will then be titrated according to dynamic compliance (Cdyn = VT / [Ppeak - PEEP])(Ppeak: Peak airway pressure)(VT:Tidal volume). Tidal volume will be set at 7 ml/kg, respiratory rate 12/min, and positive end expiratory pressure(PEEP) reduced stepwise from 20 cmH₂O to 5 cmH₂O in increments of 2 cmH₂O. Each positive end expiratory pressure(PEEP) level (19, 17, 15, 13, 11, 9, 7, 5 cmH₂O) will be maintained for 10 respiratory cycles, with Cdyn measured at the end of each level. The positive end expiratory pressure(PEEP) corresponding to the highest dynamic compliance will be selected and maintained throughout the surgery.In both groups, a 30% t-pause will be applied throughout the operation after intubation. Patients will be ventilated in volume-controlled ventilation (VCV) mode.

  • Standard VentilationProcedure or surgery

    After intubation, both groups will initially receive conventional ventilation in volume-controlled mode with a tidal volume of 7 ml/kg (predicted body weight), positive end expiratory pressure(PEEP) of 5 cmH₂O, and an inspiratory-to-expiratory ratio of 1:2. Respiratory rate will be adjusted to maintain end-tidal CO₂ between 35-45 mmHg. Following prone positioning, a recruitment maneuver will be performed using pressure-controlled ventilation, gradually increasing positive end expiratory pressure(PEEP) from 5 to 20 cmH₂O and holding for 20 seconds. After recruitment, the standard ventilation group will continue with the initial ventilator settings until the end of the surgery. Patients will be ventilated in volume-controlled ventilation (VCV) mode.

Study groups in NCT07349719
Study groupRoleWhat they receive
Dynamic Compliance Guided VentilationActive comparatorPatients receive intraoperative ventilation adjusted according to real time dynamic compliance monitoring
Receives: Procedure: Dynamic Compliance Guided Ventilation
Standart VentilationActive comparatorPatients receive intraoperative ventilation based on conventional standart settings without dynamic compliance adjustment
Receives: Procedure: Standard Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Lung Ultrasound Score

    The assessment will be performed using the Modified Lung Ultrasound Scoring system. The scale ranges from a minimum of 0 to a maximum of 36 points. A score of 0 indicates normal aeration in all zones, while a score of 36 represents the worst possible aeration loss. Higher scores indicate a worse outcome (increased lung aeration loss/atelectasis).

    Measured: baseline, postoperative 1th hour, postoperative 24th hour

Secondary outcomes (10)

  1. Incidence postoperative pulmonary complications(PPC)

    Number of participants with at least one postoperative pulmonary complication (including atelectasis, pneumonia, bronchospasm, hypoxemia, or reintubation) within the first 7 days after surgery.

    Percentage of participants

    Measured: postoperative first 7 days

  2. Intraoperative Dynamic Compliance (Cdyn)

    Mean dynamic respiratory compliance measured during the intraoperative period. Unit of Measure: mL/cmH2O

    Measured: intraoperative

  3. Intraoperative Plateau Pressure (Pplat)

    Mean airway plateau pressure measured during the intraoperative period. Unit of Measure: cmH2O

    Measured: intraoperative

  4. Intraoperative Driving Pressure (ΔP)

    Mean airway Driving Pressure measured during the intraoperative period. Unit of Measure: cmH2O

    Measured: intraoperative

  5. Intraoperative Peak Pressure (Ppeak)

    Mean airway Peak Pressure measured during the intraoperative period. Unit of Measure: cmH2O

    Measured: intraoperative

  6. Mean arterial pressure(MAP)

    Mean arterial pressure(MAP)

    Measured: Baseline,intraoperative,1st hour postoperatively.

  7. Heart Rate

    Heart Rate

    Measured: Baseline,intraoperative,1st hour postoperatively.

  8. Length of stay

    Hospitalization duration

    Measured: From date of surgery until date of hospital discharge

  9. Partial pressure of oxygen

    arterial blood oxygen partial pressure

    Measured: Baseline, intraoperative,1st hour postoperatively.

  10. SPO2

    Measurement of non invasive oxygen saturation

    Measured: Baseline,intraoperative,1st hour postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start22 Jan 2026
  3. Primary completion20 May 2026
  4. Study completion1 Jun 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349719
Sponsor's protocol ID
1-25-1645
Status last verified
Jun 2026
First submitted
29 Dec 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bao C, Cao H, Shen Z, Hu Y, Huang J, Shu Q, Chen Q. Comparison of volume-controlled ventilation, pressure-controlled ventilation and pressure-controlled ventilation-volume guaranteed in infants and young children in the prone position: A prospective randomized study. J Clin Anesth. 2024 Aug;95:111440. doi: 10.1016/j.jclinane.2024.111440. Epub 2024 Mar 8.

    PubMed 38460413

  • Chun EH, Baik HJ, Moon HS, Jeong K. Comparison of low and high positive end-expiratory pressure during low tidal volume ventilation in robotic gynaecological surgical patients using electrical impedance tomography: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):641-648. doi: 10.1097/EJA.0000000000001047.

    PubMed 31306184

  • Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.

    PubMed 32388650

  • Kim YJ, Kim BR, Kim HW, Jung JY, Cho HY, Seo JH, Kim WH, Kim HS, Hwangbo S, Yoon HK. Effect of driving pressure-guided positive end-expiratory pressure on postoperative pulmonary complications in patients undergoing laparoscopic or robotic surgery: a randomised controlled trial. Br J Anaesth. 2023 Nov;131(5):955-965. doi: 10.1016/j.bja.2023.08.007. Epub 2023 Sep 9.

    PubMed 37679285

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Compliance Guided Ventilation and Standard Ventilation in people with Lumbar Spine Stenosis and Lumbar Disc Herniation, run by Ankara City Hospital Bilkent 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Lung Ultrasound Score (time frame: baseline, postoperative 1th hour, postoperative 24th hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349719, which also lists 4 linked publications.

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 9 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in