PCV-VG in Pediatric Laparoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-8
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA physical status I-II.
Both sexes.
Age: 1-8 years old.
Scheduled for elective abdominal or urologic laparoscopic surgery.
Disqualifiers
ASA physical status more than II.
Pre-existing lung disease.
Pre-operative chest infection.
Any thoracic deformities.
Trial design
Design model
Parallel
Treatments tested in this trial
Mechanical Ventilation Mode
DeviceEach arm will have a different ventilation mode according to the allocation.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Pressure control ventilation-volume guarantee (PCV-VG) groupActive comparator 1 intervention
Group B: Pressure control ventilation (PCV) groupActive comparator 1 intervention
Group C: Volume control ventilation (VCV) groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lung dynamic compliance (Cdyn)
Dynamic compliance represents pulmonary compliance during periods of gas flow, such as during active inspiration.
Time frame
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
1
PaO2
The PaO2 partial pressure from arterial blood gas analysis will be recorded.
Time frame
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)2
SpO2%
The peripheral arterial saturation will be recorded.
Time frame
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)3
PaCO2
The PaCo2 partial pressure from arterial blood gas analysis will be recorded.
Time frame
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)4
End-tidal CO2
The end-tidal CO2 will be recoded from the main stream capnography
Time frame
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)Sponsors and contacts
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Source ClinicalTrials.gov