Comparing Different Startegies of Positive Pressure Ventilation in Children

Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study

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,

Study Overview

• Status: Recruiting
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Other: volume controlled ventilation; Other: pressure controlled ventilation; Other: pressure controlled volume grantanteed ventilation

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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana AS Mansour, MD; Phone Number: Benisuef 01222960009; Email: mrmrsyk4@gmail.com

Study Locations

• Egypt
  • Benisuef, Egypt
    • Recruiting
    • Benisuef University Hospital
    • Contact: Mariana As Mansour, MD; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vCV group; Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.	Other: volume controlled ventilation; Pediatric patients in the VCV group (n= 30) received volume-controlled ventilation, target tidal volume was set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.
Active Comparator: PCV group; Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.	Other: pressure controlled ventilation; Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.
Active Comparator: PCV-VG group; Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.	Other: pressure controlled volume grantanteed ventilation; Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(PIP)	peak inspiratory pressure	within one hour
Pplat	plateau airway pressure	within one hour
(Cdyn)	pulmonary dynamic compliance	within one hour
(RAW	airway resistance	within one hour
VT	exhaled tidal volume	within one hour
EtCO2	end-expiratory carbon dioxide	within one hour
Vd/VT	physiologic dead space over tidal volume	within one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(MAP)	mean arterial pressure	within one hour
(HR)	heart rate	within one hour
postoperative respiratory adverse events	cough, hoarseness, sore throat, hypoxemia, laryngospasm, bronchospasm.	within 24 hour

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Mariana as Mansour, MD, benisuef university hospital Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 21, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMBSUREC/01092024/Mansour

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No