PCV-VG in Pediatric Laparoscopic Surgery

NCT06245317 | Recruiting DMC

• 1 other identifier: 04-2023-200588
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Complication; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• PaO2

  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%

  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

  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

  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

  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)

Study Arms (3)

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

ACTIVE COMPARATOR

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

Pressure control ventilation (PCV) group

ACTIVE COMPARATOR

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

Volume control ventilation (VCV) group

ACTIVE COMPARATOR

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

Interventions

Mechanical Ventilation Mode DEVICE

Each arm will have a different ventilation mode according to the allocation.

Pressure control ventilation (PCV) group; Pressure control ventilation-volume guarantee (PCV-VG) group; Volume control ventilation (VCV) group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, Egypt

RECRUITING

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut University

  STUDY DIRECTOR

• Yara H Abbas, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud M Khalil, MBBS

CONTACT

1068434214; mahmoud.muhammed1997@gmail.com

Hala S Abdel-Ghaffar, MD

CONTACT

+201003812011; hallasaad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 7, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)