Comparing Different Startegies of Positive Pressure Ventilation in Children

NCT ID: NCT06612125

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-30

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.

Conditions

Ventilation Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

volume controlled ventilation

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

pressure controlled ventilation

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

pressure controlled volume grantanteed ventilation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mariana Soliman

egypt benisuef

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana as Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

benisuef university hospital Egypt

Locations

Benisuef university hospital

Benisuef, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mariana AS Mansour, MD

Role: CONTACT

mrmrsyk4@gmail.com

01222960009 ext. Benisuef

Facility Contacts

Mariana As Mansour, MD

Role: primary

mrmrsyk4@gmail.com

01222960009

Other Identifiers

FMBSUREC/01092024/Mansour

Identifier Type: -

Identifier Source: org_study_id