Actively Recruiting
Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study
Led by Beni-Suef University · Updated on 2025-01-09
78
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different methods of positive pressure ventilation in young children undergoing laparoscopic inguinal hernia repair using a laryngeal mask airway. This trial compares volume-controlled ventilation (VCV), pressure-controlled ventilation (PCV), and pressure-controlled volume-guaranteed ventilation (PCV-VG) to understand their effects on airway pressures and ventilation during surgery. The study is sponsored by Beni-Suef University and involves children aged 1 to 5 years. The trial has three groups of pediatric patients receiving different ventilation strategies during anesthesia. The VCV group receives volume-controlled ventilation with a target tidal volume of 7 mL/kg and respiratory rate of 16 breaths/min. The PCV group receives pressure-controlled ventilation with peak inspiratory pressure adjusted to provide 7 mL/kg tidal volume and a respiratory rate of 16 breaths/min, with a peak inspiratory pressure cap at 20 cm H2O. The PCV-VG group receives pressure-controlled volume-guaranteed ventilation with similar tidal volume and breathing rate settings. Participants will be monitored during surgery for airway pressures, lung compliance, airway resistance, tidal volume, carbon dioxide levels, and other respiratory parameters within one hour. Researchers will also observe postoperative respiratory adverse events for 24 hours after surgery. The study includes physical status assessments and will track heart rate and mean arterial pressure during the observation period. Participation lasts from pre-surgery through 24 hours post-operation.
CONDITIONS
Brief Title
Comparing Different Startegies of Positive Pressure Ventilation in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 5 years
- Scheduled for laparoscopic inguinal hernia repair
- American Society of Anesthesiologists physical status classification of I or II
You will not qualify if you...
- Cardiopulmonary disease
- Severe liver or kidney dysfunction
- Upper respiratory tract infection within 2 weeks before surgery
- Overweight by more than 20% of standard body weight
- Neuromuscular disease
- Anticipated difficult airway
- Hiatus hernia or gastroesophageal reflux disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure duration (within one hour)
Participants undergo laparoscopic inguinal hernia repair under general anesthesia with a laryngeal mask airway and receive one of three positive pressure ventilation strategies during surgery: volume-controlled ventilation, pressure-controlled ventilation, or pressure-controlled volume-guaranteed ventilation.
1 visit (in-person, day of surgery)
Duration - 24 hours after surgery
Participants are monitored for postoperative respiratory adverse events and vital signs.
Approximately 1 follow-up visit within 24 hours
Trial Site Locations
Total: 1 location
1
Benisuef university hospital
Benisuef, Egypt
Actively Recruiting
Research Team
M
Mariana AS Mansour, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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