Comparing Three Positive Pressure Ventilation Methods in Young Children Using Laryngeal Mask Airway During Laparoscopic Inguinal Hernia Surgery
Led by Beni-Suef University · Updated on 2025-01-09
78
Participants Needed
1
Research Sites
4 weeks
Total Duration
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 mLkg and respiratory rate of 16 breathsmin. The PCV group receives pressure-controlled ventilation with peak inspiratory pressure adjusted to provide 7 mLkg tidal volume and a respiratory rate of 16 breathsmin, 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
Research Team
M
Mariana AS Mansour, MD
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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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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)
Post-operative Follow-up
Duration - 24 hours after surgery
Participants are monitored for postoperative respiratory adverse events and vital signs.
Approximately 1 follow-up visit within 24 hours
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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Published Research Related To This Trial
Comparison of positive pressure ventilation strategies in young children undergoing laparoscopic inguinal hernia repair with laryngeal mask airway: a prospective randomized study.