Comparing Different Startegies of Positive Pressure Ventilation in Children

Not Applicable

Recruiting

• Conditions: Ventilation Therapy; Complications
• Interventions: Other: volume controlled ventilation; Other: pressure controlled ventilation; Other: pressure controlled volume grantanteed ventilation

• Registration Number: NCT06612125
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-21
• Study First Posted: 2024-09-25
• Study Start: 2024-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
vCV group	volume 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.
PCV group	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.
PCV-VG group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Benisuef university hospital; 🇪🇬 Benisuef, Egypt