Clinical trial NCT06245317: PCV-VG in Pediatric Laparoscopic Surgery
Official title: Effects of Pressure Controlled-volume Guarantee Ventilation on Respiratory Mechanics in Pediatric Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia Complication
Mechanical Ventilation Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 paediatrics laparoscopic surgery.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Lung dynamic compliance (Cdyn)
timeFrame: 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 outcomes:
measure: PaO2
timeFrame: 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)
measure: SpO2%
timeFrame: 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)
measure: PaCO2
timeFrame: 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)
measure: End-tidal CO2
timeFrame: 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)
measure: Mean airway pressure
timeFrame: 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)
measure: Peak inspiratory pressure
timeFrame: 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)
measure: Tidal volume
timeFrame: 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)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
state: Asyut
Study officials:
affiliation: Assiut University
name: Hala S Abdel-Ghaffar, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Yara H Abbas, MD
role: STUDY_DIRECTOR
References: