Comparing ventilation methods in pediatric laparoscopic surgery
Effects of Pressure Controlled-volume Guarantee Ventilation on Respiratory Mechanics in Pediatric Laparoscopic Surgery
This study is testing which breathing method works best to keep kids safe and breathing well during laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 1 Year to 8 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT06245317 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics and oxygenation during pediatric laparoscopic surgery. The research focuses on addressing the respiratory complications that arise from carbon dioxide insufflation and elevated intra-abdominal pressure, which can lead to significant decreases in pulmonary compliance and increased airway pressures. By evaluating these ventilation modes, the study seeks to identify the most effective approach to minimize adverse respiratory effects in children undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-8 years scheduled for elective abdominal or urologic laparoscopic surgery with ASA physical status I-II.
Not a fit: Patients with pre-existing lung disease, significant thoracic deformities, or those with ASA physical status greater than II may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance respiratory management during pediatric laparoscopic surgeries, leading to improved patient outcomes and reduced complications.
How similar studies have performed: While there have been studies on ventilation methods in adults, this specific comparison in pediatric laparoscopic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status I-II. * Both sexes. * Age: 1-8 years old. * Scheduled for elective abdominal or urologic laparoscopic surgery. * BMI between the 5th and 95th percentiles. Exclusion Criteria: * ASA physical status more than II. * Pre-existing lung disease. * Pre-operative chest infection. * Any thoracic deformities. * Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level. * Patients with cardiac, hepatic, or renal diseases. * BMI above and below the 95th and 5th percentile respectively.
Where this trial is running
Asyut, Asyut Governorate
- Assiut University Hospital — Asyut, Asyut Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud M Khalil, MBBS
- Email: mahmoud.muhammed1997@gmail.com
- Phone: 1068434214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.