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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age below 18 or above 75 years

ASA physical status IV-V

Emergency surgical procedure

Severe chronic or restrictive pulmonary disease

Trial population

Adult patients scheduled for elective laparoscopic unilateral inguinal hernia repair under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard PEEP Ventilation

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: standard PEEP1 intervention
Group B: Individualized PEEP1 intervention

Trial outcomes

Primary outcomes

1

Perioperative Oxygenation Assessed by Oxygen Reserve Index (ORI)

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
From anesthesia induction to postoperative 20 minutes (approximately 3 hours)

Secondary outcomes

1

Perioperative Atelectasis Assessed by Lung Ultrasound Score

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
Preoperatively and at postoperative 20 minutes
2

Dynamic Lung Compliance (Cdyn)

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
3

Arterial Partial Pressure of Oxygen (PaO₂)

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
From anesthesia induction to 20 minutes after admission to the post-anesthesia care unit
4

Postoperative Pulmonary Complications

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
Up to 7 days after surgery

Other outcomes

Sponsors and contacts

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