PCV-VG in Pediatric Laparoscopic Surgery

Mechanical Ventilation Complication Clinical Trial

Official title:

Effects of Pressure Controlled-volume Guarantee Ventilation on Respiratory Mechanics in Pediatric Laparoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245317
• Other study ID #: 04-2023-200588
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Mahmoud M Khalil, MBBS
• Phone: 1068434214
• Email: mahmoud.muhammed1997[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Complication
• Mechanical Ventilation Complication

Intervention

Device:
• Mechanical Ventilation Mode
Each arm will have a different ventilation mode according to the allocation.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung dynamic compliance (Cdyn)	Dynamic compliance represents pulmonary compliance during periods of gas flow, such as during active inspiration.	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	PaO2	The PaO2 partial pressure from arterial blood gas analysis will be recorded.	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	SpO2%	The peripheral arterial saturation will be recorded.	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	PaCO2	The PaCo2 partial pressure from arterial blood gas analysis will be recorded.	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	End-tidal CO2	The end-tidal CO2 will be recoded from the main stream capnography	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	Mean airway pressure	The mean airway pressure will be recorded from the ventilator electronic display in the GE anesthesia machine	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	Peak inspiratory pressure	The PIP will be recorded from the ventilator electronic display in the GE anesthesia machine	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary	Tidal volume	The exhaled tidal volume will be recorded from the ventilator electronic display in the GE anesthesia machine	5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)