PCV-VG in Pediatric Laparoscopic Surgery

Assiut University

Status: Enrolling

Conditions: Mechanical Ventilation Complication; Anesthesia Complication

Treatments: Device: Mechanical Ventilation Mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06245317

04-2023-200588

Details and patient eligibility

About

This Study will aim to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in pediatric laparoscopic surgery.

Full description

Laparoscopic surgery is superior to open surgery in terms of recovery time, less postoperative pain, less wound complications, shorter hospital stay, and earlier return to work. However, carbon dioxide insufflation causes several intraoperative cardiovascular, renal, and respiratory adverse effects. Regarding respiratory effects, elevated Intra-abdominal pressure and abdominal expansion shifts the diaphragm upwards. Thus, intrathoracic pressure increases, and expansion of the lungs is restricted. This is followed by a significant decrease up to 50% in pulmonary dynamic compliance and an increase in peak and plateau airway pressures. After deflation of pneumoperitoneum both the pulmonary compliance and airway pressures return to the baseline levels. High airway pressures and decreased compliance can be associated with pulmonary barotrauma, which may manifest as immediate pneumothorax. The basal lung regions are compressed during elevated IAP causing atelectasis and uneven ventilation-perfusion relationships, impairing gas exchange. Hence, the choice of ventilation mode is very important, especially in the paediatric population. Volume control ventilation (VCV) and pressure control ventilation (PCV) modes have been used but each has its own drawbacks, with the former risking increase in airway pressure when pulmonary compliance changes which can lead to barotrauma and the latter not guaranteeing the desired tidal volume which leads to hypoventilation that presents with hypercarbia. Pressure Control Ventilation - Volume Guarantee (PCV-VG) is a recent controlled ventilation mode that combines the benefits of both volume control ventilation (VCV) and pressure control ventilation (PCV) by delivering the preset tidal volume with a decelerating flow at the lowest possible peak inspiratory pressure during a preset inspiratory time and at a preset respiratory rate ensuring adequate ventilation .

Enrollment: 75 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status I-II.
• Both sexes.
• Age: 1-8 years old.
• Scheduled for elective abdominal or urologic laparoscopic surgery.
• BMI between the 5th and 95th percentiles.

Exclusion criteria

• ASA physical status more than II.
• Pre-existing lung disease.
• Pre-operative chest infection.
• Any thoracic deformities.
• Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level.
• Patients with cardiac, hepatic, or renal diseases.
• BMI above and below the 95th and 5th percentile respectively.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Pressure control ventilation-volume guarantee (PCV-VG) group

Active Comparator group

Description:

In the PCV-VG group the tidal volume will be set to 8-10ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO¬2.

Treatment:

Device: Mechanical Ventilation Mode

Pressure control ventilation (PCV) group

Active Comparator group

Description:

In the PCV group peak inspiratory pressure will be set to 10-15 cm H2O titrated to achieve 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal Co2

Treatment:

Device: Mechanical Ventilation Mode

Volume control ventilation (VCV) group

Active Comparator group

Description:

In the VCV group tidal volume will be set to 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO2,

Treatment:

Device: Mechanical Ventilation Mode