PCV-VG in Pediatric Laparoscopic Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanical Ventilation Complication; Anesthesia Complication
• Intervention / Treatment: Device: Mechanical Ventilation Mode

Detailed 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 .

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud M Khalil, MBBS; Phone Number: +20 1068434214; Email: mahmoud.muhammed1997@gmail.com
• Study Contact Backup: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +201003812011; Email: hallasaad@yahoo.com

Study Locations

• Egypt
  • Asyut
    • Assiut, Asyut, Egypt
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure control ventilation-volume guarantee (PCV-VG) group; 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.	Device: Mechanical Ventilation Mode; Each arm will have a different ventilation mode according to the allocation.
Active Comparator: Pressure control ventilation (PCV) group; 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	Device: Mechanical Ventilation Mode; Each arm will have a different ventilation mode according to the allocation.
Active Comparator: Volume control ventilation (VCV) group; 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,	Device: Mechanical Ventilation Mode; Each arm will have a different ventilation mode according to the allocation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Hala S Abdel-Ghaffar, MD, Assiut University; Study Director: Yara H Abbas, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 04-2023-200588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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