ObesityNCT07388719
Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP in Obese Patients Undergoing Spinal Surgery
A study testing Standard PEEP in people with Obesity and Postoperative Pulmonary Complications, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Postoperative Pulmonary Complications, Mechanical Ventilation
- What is being tested?
- Standard PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2025to 12 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- Scheduled for elective spinal surgery under general anesthesia
- Requirement for intraoperative mechanical ventilation
- American Society of Anesthesiologists (ASA) physical status II-III
- Provision of written informed consent
Who cannot join
- Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
- Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
- History of thoracic surgery affecting lung mechanics
- Pregnancy
- Emergency surgery
- Intraoperative need for deviation from the planned ventilation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Interventional Study Comparing Standard and Dynamic Compliance-Guided Individualized Positive End-Expiratory Pressure on Intraoperative Oxygenation and Postoperative Pulmonary Complications in Obese Patients Undergoing Spinal Surgery
This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.
Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.
The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.
- Being tested
- Standard PEEP
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PEEPDevice
Application of a fixed positive end-expiratory pressure of 5 cmH₂O during intraoperative mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Standard PEEP | Active comparator | Patients assigned to this arm receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the intraoperative period during mechanical ventilation. Receives: Device: Standard PEEP |
| Dynamic Compliance-Guided Individualized PEEP | Experimental | Patients assigned to this arm receive individualized positive end-expiratory pressure (PEEP) titrated according to intraoperative dynamic lung compliance, with the aim of optimizing respiratory mechanics while avoiding overdistension. Receives: Device: Standard PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
The primary outcome is intraoperative oxygenation assessed by the arterial partial pressure of oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratio during mechanical ventilation.
Measured: From induction of anesthesia until the end of surgery
Secondary outcomes (4)
Dynamic Lung Compliance
Dynamic lung compliance (mL/cmH₂O) measured intraoperatively via ventilator respiratory mechanics monitoring.
Measured: From induction of anesthesia until the end of surgery
Static Lung Compliance
Static lung compliance (mL/cmH₂O) measured intraoperatively via ventilator plateau pressure analysis.
Measured: From induction of anesthesia until the end of surgery
Peak Airway Pressure
Peak inspiratory airway pressure (cmH₂O) measured intraoperatively using ventilator monitoring.
Measured: From induction of anesthesia until the end of surgery
Plateau Airway Pressure
Plateau airway pressure (cmH₂O) measured intraoperatively during mechanical ventilation.
Measured: From induction of anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start2 Feb 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 are assigned to one of two parallel groups receiving either standard fixed PEEP or dynamic compliance-guided individualized PEEP during surgery.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388719
- Sponsor's protocol ID
- NEU-2024-5206
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study Comparing Standard and Dynamic Compliance-Guided Individualized Positive End-Expiratory Pressure on Intraoperative Oxygenation and Postoperative Pulmonary Complications in Obese Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT07388719
- Acronym / sponsor ID
- NEU-2024-5206
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 5 Feb 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 study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.
Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.
The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two parallel groups receiving either standard fixed PEEP or dynamic compliance-guided individualized PEEP during surgery.
| Arm | Type | Receives |
|---|---|---|
| Standard PEEP | Active comparator | Device: Standard PEEPPatients assigned to this arm receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the intraoperative period during mechanical ventilation. |
| Dynamic Compliance-Guided Individualized PEEP | Experimental | Device: Standard PEEPPatients assigned to this arm receive individualized positive end-expiratory pressure (PEEP) titrated according to intraoperative dynamic lung compliance, with the aim of optimizing respiratory mechanics while avoiding overdistension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- Scheduled for elective spinal surgery under general anesthesia
- Requirement for intraoperative mechanical ventilation
- American Society of Anesthesiologists (ASA) physical status II-III
Key exclusion criteria (6 listed)
- Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
- Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
- History of thoracic surgery affecting lung mechanics
- Pregnancy
- Emergency surgery
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 |
|---|---|---|
| Standard PEEPApplication of a fixed positive end-expiratory pressure of 5 cmH₂O during intraoperative mechanical ventilation. | Device | Dynamic Compliance-Guided Individualized PEEP, Standard PEEP |
Primary outcome
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
Time frame: From induction of anesthesia until the end of surgery
The primary outcome is intraoperative oxygenation assessed by the arterial partial pressure of oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratio during mechanical ventilation.
4 secondary outcomes
Dynamic Lung Compliance
Time frame: From induction of anesthesia until the end of surgery
Static Lung Compliance
Time frame: From induction of anesthesia until the end of surgery
Peak Airway Pressure
Time frame: From induction of anesthesia until the end of surgery
Plateau Airway Pressure
Time frame: From induction of anesthesia until the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PEEP in people with Obesity and Postoperative Pulmonary Complications, run by Konya 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 6 inclusion and 6 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 5 Feb 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?
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio) (time frame: From induction of anesthesia until the end of surgery). 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 5 Feb 2026.