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NCT Number: NCT07543939

Peak Airway Pressure and Respiratory Mechanics During PRVC Ventilation in Laparoscopic Surgery

This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.

The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.

Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.

This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at predefined time points: after induction, after pneumoperitoneum, and at steady-state intraoperative conditions.

The primary outcome will be peak airway pressure. Secondary outcomes include dynamic compliance and other ventilatory parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 18-65 years
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia
  • ASA physical status I-II
  • Patients requiring mechanical ventilation using PRVC mode
  • Provided informed consent

Exclusion criteria

  • Patients with significant cardiopulmonary disease
  • Chronic obstructive pulmonary disease or restrictive lung disease
  • Morbid obesity (BMI > 35 kg/m²)
  • Pregnancy
  • Emergency surgeries
  • Patients with anticipated difficult airway
  • Refusal to participate

Treatment and study plan

PRVC ventilation

Other

Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced.

Primary outcomes

  1. Peak Airway Pressure

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings.

Secondary outcomes

  1. Dynamic Compliance

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Dynamic lung compliance (Cdyn) measured intraoperatively using standard anesthesia monitoring at predefined time points.

  2. Plateau Pressure

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Plateau pressure (Pplat) measured during controlled ventilation using the anesthesia workstation.

  3. End-tidal Carbon Dioxide

    Time frame: At 0, 5, and 10 minutes intraoperatively

    End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation.

  4. Mean Airway Pressure

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Mean airway pressure measured intraoperatively using the anesthesia workstation.

  5. Oxygen Saturation

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Peripheral oxygen saturation (SpO2) monitored continuously during surgery.

  6. Heart Rate (beats/min)

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Heart rate measured intraoperatively using standard monitoring

  7. Mean Arterial Pressure (mmHg)

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Mean arterial pressure measured intraoperatively using standard monitoring

  8. Minute Ventilation

    Time frame: At 0, 5, and 10 minutes intraoperatively

    Minute ventilation recorded from the anesthesia workstation during controlled ventilation.

Study contacts

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

Salaheldin A Abdelaziz Ahmed, MD

CONTACT

[email protected]

+201001308006

Sponsors and collaborators

Lead sponsor

Specialized Medical Center (SMC)

Other

Registry information

Official study title

Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 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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