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NCT Number: NCT07775573

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location contact

sena sancak, MD

CONTACT

[email protected]

+905428361205

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard PEEP Ventilation

Procedure

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

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.

Primary outcomes

  1. Perioperative Oxygenation Assessed by Oxygen Reserve Index (ORI)

    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.

Secondary outcomes

  1. Perioperative Atelectasis Assessed by Lung Ultrasound Score

    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.

  2. Dynamic Lung Compliance (Cdyn)

    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

  3. Arterial Partial Pressure of Oxygen (PaO₂)

    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.

  4. Postoperative Pulmonary Complications

    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.

  5. Arterial Partial Pressure of Carbon Dioxide (PaCO₂)

    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.

  6. Arterial Blood pH

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

sena solmaz, MD

CONTACT

[email protected]

+905428361205

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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