Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34000, Turkey (Türkiye)
NCT Number: NCT07775573
During laparoscopic surgery under general anesthesia, lung function can be affected by increased abdominal pressure and patient positioning. Positive end-expiratory pressure (PEEP) is a ventilator setting that helps keep the lungs open during surgery. In standard practice, a fixed PEEP level is applied to all patients. An individualized PEEP approach tailors this setting to each patient based on lung recruitment maneuvers.
This study investigates whether individualized PEEP improves oxygenation compared to standard PEEP in patients undergoing laparoscopic inguinal hernia surgery. Oxygenation will be continuously monitored using the Oxygen Reserve Index (ORI), a non-invasive sensor. Lung aeration will also be assessed before and after surgery using bedside lung ultrasound.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Istanbul, 34000, Turkey (Türkiye)
General anesthesia combined with pneumoperitoneum and Trendelenburg positioning significantly alters respiratory mechanics. These changes can reduce functional residual capacity (FRC), promote atelectasis, and impair gas exchange - particularly in laparoscopic surgery.
Individualized PEEP, determined through a recruitment maneuver followed by PEEP titration, has been shown to reduce driving pressure and improve dynamic lung compliance compared to fixed PEEP strategies.
The Oxygen Reserve Index (ORI) is a novel non-invasive monitoring parameter that continuously tracks partial oxygen pressure changes in the 100-200 mmHg range, providing early warning of desaturation before SpO2 drops.
In this prospective observational study, 60 adult patients (ASA I-III, aged 18-75) scheduled for elective laparoscopic unilateral inguinal hernia repair under general anesthesia will be enrolled. Patients will receive either standard PEEP (5 cmH₂O) or individualized PEEP based on the attending anesthesiologist's routine clinical preference.
Hemodynamic and respiratory parameters including ORI, SpO2, airway pressures, tidal volume, dynamic compliance, and BIS will be recorded at six time points: before anesthesia (T0), 5 minutes post-intubation (T1), 10 minutes post-Trendelenburg (T2), 20 minutes post-Trendelenburg (T3), after desufflation (T4), and at postoperative 20 minutes (T5).
Lung ultrasound scoring (0-3 per zone, 12-zone protocol) will be performed preoperatively and postoperatively to assess atelectasis. Arterial blood gas analysis will provide additional oxygenation data.
The primary outcome is the effect of individualized versus standard PEEP on perioperative oxygenation as measured by ORI. The secondary outcome is the comparison of atelectasis prevention efficacy between the two PEEP strategies assessed by lung ultrasound score.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O applied throughout the surgical procedure. Volume-controlled ventilation mode with tidal volume 6-8 ml/kg ideal body weight, inspiratory-to-expiratory ratio 1:2, and fraction of inspired oxygen (FiO₂) 0.40. Respiratory rate adjusted to maintain end-tidal CO₂ (EtCO₂) between 35-40 mmHg. No recruitment maneuver is performed.
Individualized PEEP determined by a stepwise recruitment maneuver followed by PEEP titration, applied at 10 minutes after Trendelenburg positioning. The optimal PEEP level is identified based on best dynamic lung compliance and maintained for the remainder of surgery. All other ventilation parameters are identical: volume-controlled mode, tidal volume 6-8 ml/kg, I/E ratio 1:2, FiO₂ 0.40, EtCO₂ 35-40 mmHg.
Time frame: From anesthesia induction to postoperative 20 minutes (approximately 3 hours)
Continuous non-invasive monitoring of the Oxygen Reserve Index (ORI) to assess perioperative oxygenation. ORI values range from 0 to 1 and reflect partial oxygen pressure changes in the 100-200 mmHg range. ORI is recorded at six time points: before anesthesia induction (T0), 5 minutes after intubation (T1), 10 minutes after Trendelenburg positioning (T2), 20 minutes after Trendelenburg positioning (T3), after desufflation (T4), and at postoperative 20 minutes (T5). ORI values will be compared between the standard PEEP and individualized PEEP groups.
Time frame: Preoperatively and at postoperative 20 minutes
Lung aeration assessed using a 12-zone lung ultrasound protocol in supine position. Each zone is scored 0-3: 0 = normal aeration (A-lines, fewer than 3 B-lines), 1 = mild interstitial syndrome (3 or more well-defined B-lines), 2 = moderate interstitial syndrome (confluent B-lines), 3 = severe interstitial syndrome or lung consolidation. Total score ranges from 0 to 36. Scores will be compared between standard PEEP and individualized PEEP groups.
Time frame: From anesthesia induction to 20 minutes after admission to the post-anesthesia care unit
Dynamic lung compliance (Cdyn), expressed in mL/cmH₂O, recorded from the anesthesia ventilator at six predefined perioperative time points. All six observations represent repeated measurements of the same outcome using the same unit of measure
Time frame: From anesthesia induction to 20 minutes after admission to the post-anesthesia care unit
Arterial partial pressure of oxygen (PaO₂), measured in mmHg in blood samples obtained through the radial arterial cannula at the predefined time points.
Time frame: Up to 7 days after surgery
Incidence of postoperative pulmonary complications including desaturation, dyspnea, pneumonia, or respiratory-related hospital readmission assessed at postoperative day 7 via telephone follow-up.
Time frame: From anesthesia induction to 20 minutes after admission to the post-anesthesia care unit
Arterial partial pressure of carbon dioxide (PaCO₂), measured in mmHg in blood samples obtained through the radial arterial cannula at the predefined time points.
Time frame: From anesthesia induction to 20 minutes after admission to the post-anesthesia care unit
Arterial blood pH, reported as a unitless numerical value in blood samples obtained through the radial arterial cannula at the predefined time points.
Contact information is provided by the study sponsor or research team.
Fatih Sultan Mehmet Training and Research Hospital
Other
The Effect of Individualized Positive End-Expiratory Pressure Application on Perioperative Oxygenation Assessed by Oxygen Reserve Index Compared to Standard PEEP in Patients Undergoing Laparoscopic Inguinal Hernia Surgery: A Prospective Observational Study
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