- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06462976
Postoperative Pulmonary Complications in Adult PNL Patients
The Effect of Intraoperative Position and Mechanical Power on Postoperative Pulmonary Complications in Adult PNL(Percutaneous Nephrolithotomy) Patients
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kayseri
-
Kayseri, Kayseri, Turkey (Türkiye)
- Gamze Talih
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who will undergo elective percutaneous nephrolithotomy and agree to participate in the study.
- ASA 1-3 patient
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mechanical power
Time Frame: 2 year
|
mechanical power=0.098*minute
ventilation *(Ppeak-0.5*(Pplato-PEEP)
|
2 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/99
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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