Actively Recruiting

Phase Not Applicable
Age: 1Year - 5Years
All Genders
Healthy Volunteers
ID06612125

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

Age: 1Year - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Trial Site Locations

Total: 1 location

1

Benisuef university hospital

Benisuef, Egypt

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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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