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NCT Number: NCT06245317

PCV-VG 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.

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, Egypt

Location status: Recruiting

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical Ventilation Mode

Device

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

Primary outcomes

  1. Lung dynamic compliance (Cdyn)

    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)

    Dynamic compliance represents pulmonary compliance during periods of gas flow, such as during active inspiration.

Secondary outcomes

  1. PaO2

    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)

    The PaO2 partial pressure from arterial blood gas analysis will be recorded.

  2. SpO2%

    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)

    The peripheral arterial saturation will be recorded.

  3. PaCO2

    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)

    The PaCo2 partial pressure from arterial blood gas analysis will be recorded.

  4. End-tidal CO2

    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)

    The end-tidal CO2 will be recoded from the main stream capnography

  5. Mean airway pressure

    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)

    The mean airway pressure will be recorded from the ventilator electronic display in the GE anesthesia machine

  6. Peak inspiratory pressure

    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)

    The PIP will be recorded from the ventilator electronic display in the GE anesthesia machine

  7. Tidal volume

    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)

    The exhaled tidal volume will be recorded from the ventilator electronic display in the GE anesthesia machine

Study contacts

Contact information is provided by the study sponsor or research team.

Hala S Abdel-Ghaffar, MD

CONTACT

[email protected]

+201003812011

Mahmoud M Khalil, MBBS

CONTACT

[email protected]

1068434214 ext. +20

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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