Postoperative Pulmonary ComplicationNCT06462976
Postoperative Pulmonary Complications in Adult PNL Patients
An observational study of Postoperative Pulmonary Complication and Mechanical Power, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of different surgical positions (supine/prone) on lung mechanical power (MP) and its relationship with postoperative pulmonary complications in patients planned to percutaneous nephrolithotomy (PNL) under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pulmonary Complication, Mechanical Power
- What is being tested?
- mechanical power calculation
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 Apr 2026
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are aged 18-75 agree to participate in the study
Who may be able to join
- Patients who will undergo elective percutaneous nephrolithotomy and agree to participate in the study.
- ASA 1-3 patient
Who cannot join
- Patients with acute and chronic hypoxemia (PaO2<65mmHg, SpO2<95 in room air)
- Patients with BMI>35
- Patients with obstructive sleep apnea syndrome
- Patients with ASA 4 and above
- Pregnant patients
- Pneumonia, COPD attack etc. before the operation. people with lung disease
- Unstable patients such as uncontrolled hypertension, decompensated heart
- Mentally retarded and uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Position and Mechanical Power on Postoperative Pulmonary Complications in Adult PNL(Percutaneous Nephrolithotomy) Patients
The aim of this study is to investigate the effect of different surgical positions (supine/prone) on lung mechanical power (MP) and its relationship with postoperative pulmonary complications in patients planned to percutaneous nephrolithotomy (PNL) under general anesthesia.
Read the detailed description
PNL is the preferred treatment method for kidney stones larger than 2 cm, multiple kidney stones and staghorn stones. With new developments in the field of medicine, PNL has become a minimally invasive method and is preferred to open surgery in the treatment of kidney stones. Alternative types of anesthesia and various patient positions have been described in PNL.
Mechanical power of ventilation (MP) is the amount of energy transferred from the mechanical ventilator to the respiratory system per unit time. Although this energy is primarily used to overcome airway resistance and respiratory system compliance, some of it acts directly on lung tissue, potentially causing ventilator-induced lung injury (VILI).
Mechanical power during ventilation estimates the energy delivered to the respiratory system by integrating inspiratory pressures, tidal volume and respiratory rate into a single value. It allows physicians to evaluate adjustments made to mechanical ventilation by calculating a single value. High mechanical power value is associated with a high incidence of postoperative pulmonary complications and mortality . In short, the energy distributed to the respiratory system consists of the static composite (PEEP), the dynamic composite (driving pressure and tidal volume) and the resistive composite (the pressure required for gas flow). Because energy is equal to the pressure that causes a change in volume. The equation is as follows: MP= 0.098 × respiratory rate × tidal volume × (PEEP + ½(plateau-peep)+ (peak-plateau)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation.
After general anesthesia, some postoperative pulmonary complications may be encountered. Exposure to high mechanical force in ventilated patients during surgery has been found to be associated with an increase in postoperative pulmonary complications and acute respiratory failure. This increases the length of hospital stay and mortality. In order to prevent ventilator-related lung damage, the mechanical ventilator must be adjusted to transfer the least amount of energy per unit time to the respiratory system for each patient.
Early recognition of postoperative pulmonary complications that are likely to occur after surgery is important for rapid initiation of treatment. Incentive spirometry (triflo) can be used to make a rapid assessment of the respiratory capacity of patients. An incentive spirometer is a device that measures the volume of air drawn into the lungs during inspiration. As you breathe through an incentive spirometer, a piston inside the device rises and measures the volume of inhaled air. 1 ball is considered as 600ml, 2 balls as 900ml, and 3 balls as 1200ml flow.]
- Being tested
- mechanical power calculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical power calculationOther
Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation
| Study group | Role | What they receive |
|---|---|---|
| supine | Which group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position. Receives: Other: mechanical power calculation | |
| prone | Which group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position. Receives: Other: mechanical power calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical power
mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2025
- Primary completion31 Jan 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Talih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462976
- Sponsor's protocol ID
- 2024/99
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Position and Mechanical Power on Postoperative Pulmonary Complications in Adult PNL(Percutaneous Nephrolithotomy) Patients
- ClinicalTrials.gov ID
- NCT06462976
- Acronym / sponsor ID
- 2024/99
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 17 Jun 2024 (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.
The aim of this study is to investigate the effect of different surgical positions (supine/prone) on lung mechanical power (MP) and its relationship with postoperative pulmonary complications in patients planned to percutaneous nephrolithotomy (PNL) under general anesthesia.
Detailed description
PNL is the preferred treatment method for kidney stones larger than 2 cm, multiple kidney stones and staghorn stones. With new developments in the field of medicine, PNL has become a minimally invasive method and is preferred to open surgery in the treatment of kidney stones. Alternative types of anesthesia and various patient positions have been described in PNL.
Mechanical power of ventilation (MP) is the amount of energy transferred from the mechanical ventilator to the respiratory system per unit time. Although this energy is primarily used to overcome airway resistance and respiratory system compliance, some of it acts directly on lung tissue, potentially causing ventilator-induced lung injury (VILI).
Mechanical power during ventilation estimates the energy delivered to the respiratory system by integrating inspiratory pressures, tidal volume and respiratory rate into a single value. It allows physicians to evaluate adjustments made to mechanical ventilation by calculating a single value. High mechanical power value is associated with a high incidence of postoperative pulmonary complications and mortality . In short, the energy distributed to the respiratory system consists of the static composite (PEEP), the dynamic composite (driving pressure and tidal volume) and the resistive composite (the pressure required for gas flow). Because energy is equal to the pressure that causes a change in volume. The equation is as follows: MP= 0.098 × respiratory rate × tidal volume × (PEEP + ½(plateau-peep)+ (peak-plateau)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation.
After general anesthesia, some postoperative pulmonary complications may be encountered. Exposure to high mechanical force in ventilated patients during surgery has been found to be associated with an increase in postoperative pulmonary complications and acute respiratory failure. This increases the length of hospital stay and mortality. In order to prevent ventilator-related lung damage, the mechanical ventilator must be adjusted to transfer the least amount of energy per unit time to the respiratory system for each patient.
Early recognition of postoperative pulmonary complications that are likely to occur after surgery is important for rapid initiation of treatment. Incentive spirometry (triflo) can be used to make a rapid assessment of the respiratory capacity of patients. An incentive spirometer is a device that measures the volume of air drawn into the lungs during inspiration. As you breathe through an incentive spirometer, a piston inside the device rises and measures the volume of inhaled air. 1 ball is considered as 600ml, 2 balls as 900ml, and 3 balls as 1200ml flow.]
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine | – | Other: mechanical power calculationWhich group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position. |
| prone | – | Other: mechanical power calculationWhich group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are aged 18-75 agree to participate in the study
Key inclusion criteria (2 listed)
- Patients who will undergo elective percutaneous nephrolithotomy and agree to participate in the study.
- ASA 1-3 patient
Key exclusion criteria (8 listed)
- Patients with acute and chronic hypoxemia (PaO2<65mmHg, SpO2<95 in room air)
- Patients with BMI>35
- Patients with obstructive sleep apnea syndrome
- Patients with ASA 4 and above
- Pregnant patients
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 power calculationMechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation | Other | prone, supine |
Primary outcome
mechanical power
Time frame: 2 year
mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)
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 6 May 2026.
Related trials for Postoperative Pulmonary Complication
Not yet recruiting
Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG)
Postoperative Complications
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
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?
An observational study of Postoperative Pulmonary Complication and Mechanical Power, run by TC Erciyes University 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 2 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: finished, as of the sponsor's last update on 6 May 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?
mechanical power (time frame: 2 year). 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 6 May 2026.