Clinical trial NCT06612125: Comparing Different Startegies of Positive Pressure Ventilation in Children
Official title: Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilation Therapy; Complications
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,

Detailed description: The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.

Eligibility criteria: Inclusion Criteria:

1. age between 1 and 5 years.
2. patient scheduled for laparoscopic inguinal hernia repair.
3. American Society of Anesthesiologists classification of physical status of I-II.

Exclusion Criteria:

1. cardiopulmonary disease.
2. severe hepatorenal dysfunction.
3. history of upper respiratory tract infection 2 weeks before the operation.
4. overweight \[more than 20% of standard body weight\].
5. neuromuscular disease.
6. anticipated difficult airway.
7. hiatus hernia or gastroesophageal reflux disease.

Primary outcomes:
measure: (PIP)
timeFrame: within one hour
measure: Pplat
timeFrame: within one hour
measure: (Cdyn)
timeFrame: within one hour
measure: (RAW
timeFrame: within one hour
measure: VT
timeFrame: within one hour
measure: EtCO2
timeFrame: within one hour
measure: Vd/VT
timeFrame: within one hour
Secondary outcomes:
measure: (MAP)
timeFrame: within one hour
measure: (HR)
timeFrame: within one hour
measure: postoperative respiratory adverse events
timeFrame: within 24 hour
Other outcomes:
Locations:
city: Benisuef
country: Egypt
facility: Benisuef university hospital
Study officials:
affiliation: benisuef university hospital Egypt
name: Mariana as Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References: