Comparing two ventilation methods for obese patients during laparoscopic surgery

Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery

This study is testing whether a new way of helping obese patients breathe during laparoscopic surgery works better than the standard method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 16 Years to 60 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06117748 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of pressure controlled ventilation volume-guaranteed (PCV-VG) against volume-controlled ventilation (VCV) in obese patients undergoing laparoscopic-assisted surgery, particularly in the Trendelenburg position. Obesity can complicate anesthesia and ventilation due to increased airway resistance and decreased lung compliance. The study will assess lung compliance and oxygenation index to determine which ventilation method better supports respiratory function during surgery. By adjusting ventilator parameters to maintain target volumes while minimizing airway pressure, the PCV-VG method may offer advantages over traditional VCV.

Who should consider this trial

Good fit: Ideal candidates are obese patients aged 16 to 60 with a BMI of 30 kg/m² or higher, undergoing elective laparoscopic surgery.

Not a fit: Patients with severe obesity-related complications, such as pulmonary hypertension or advanced organ disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve respiratory management and outcomes for obese patients undergoing laparoscopic surgery.

How similar studies have performed: While the specific combination of PCV-VG and VCV in this context is novel, similar studies have shown promising results in improving ventilation strategies for obese patients.

Eligibility criteria

Inclusion Criteria:

1. Age: 16 - 60 years old.
2. Sex: both males and females.
3. Undergoing elective Laparoscopic Surgery.
4. Obese patient with Body Mass Index between ≥30 Kg/m2.
5. American society of Anesthesiologist (ASA) class I/ II.

Exclusion Criteria:

1. Patient refusal.
2. American society of Anesthesiology (ASA) III or IV.
3. Intraoperative hemodynamic instability.
4. Patients with pulmonary hypertension.
5. Obese patients on home O2 therapy
6. Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
7. Anti-Trendelenburg position.
8. Asthmatic Patients.
9. Patients with advanced liver disease.
10. Patients with advanced renal disease.
11. Patients with advanced malignancy.
12. Pregnant females.

Where this trial is running

Cairo

• Ain Shams University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Ahmed M Soliman, Master

Conditions Volume-Controlled Ventilation; Pressure-Controlled Ventilation Volume Guaranteed; Obese; Laparoscopy