NCT07543939

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Oct 2026

First Submitted

Initial submission to the registry

April 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 13, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

PRVC ventilationLaparoscopic surgeryPeak airway pressureDynamic complianceGeneral anesthesiaMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Peak Airway Pressure

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

    At 0, 5, and 10 minutes intraoperatively

Secondary Outcomes (8)

  • Dynamic Compliance

    At 0, 5, and 10 minutes intraoperatively

  • Plateau Pressure

    At 0, 5, and 10 minutes intraoperatively

  • End-tidal Carbon Dioxide

    At 0, 5, and 10 minutes intraoperatively

  • Mean Airway Pressure

    At 0, 5, and 10 minutes intraoperatively

  • Oxygen Saturation

    At 0, 5, and 10 minutes intraoperatively

  • +3 more secondary outcomes

Study Arms (1)

Single Cohort

Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points.

Other: PRVC Ventilation

Interventions

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

Single Cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Salaheldin A Abdelaziz Ahmed, MD

    Specialized Medical Center (SMC), Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salaheldin A Abdelaziz Ahmed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No, individual participant data (IPD) will not be shared.