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Clinical Trials in Turkey / NCT07775573
Starting soon Observational

Individualized vs Standard PEEP and Oxygen Reserve Index in Laparoscopic Hernia Surgery

NCT07775573 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-09
Last updated
2026-08-20

Condition(s) studied

AtelectasisPerioperative OxygenationLaparoscopic Inguinal Hernia RepairMechanical Ventilation

Investigational drug(s) / intervention(s)

Standard PEEP VentilationIndividualized PEEP Ventilation

Standard PEEP Ventilation: 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 Ventilation: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18-75 years * ASA physical status I-III * Scheduled for elective laparoscopic unilateral inguinal hernia repair under general anesthesia * Body mass index (BMI) \< 35 kg/m² * Written informed consent obtained Exclusion Criteria: * Age below 18 or above 75 years * ASA physical status IV-V * Emergency surgical procedure * Severe chronic or restrictive pulmonary disease * Pulmonary hypertension * Obstructive sleep apnea syndrome * Preoperative peripheral oxygen saturation \< 94% on room air * Respiratory tract infection within the last two weeks * Severe cardiac failure (NYHA III-IV) * Pregnancy * Communication difficulties preventing NRS assessment * Surgical complications during the procedure * Operation duration exceeding 3 hours * Refusal to provide informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital Istanbul Turkey (Türkiye)

More Fatih Sultan Mehmet Training and Research Hospital trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07775573 on ClinicalTrials.gov ↗ ← All trials in Turkey