Actively Recruiting

Phase Not Applicable
Age: 1Year - 8Years
All Genders
ID06245317

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

Led by Assiut University · Updated on 2024-07-30

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how different mechanical ventilation modes affect breathing during pediatric laparoscopic surgery. This trial compares Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) with volume control ventilation (VCV) and pressure control ventilation (PCV) modes. The goal is to understand their impact on lung function and oxygen levels in children undergoing these surgeries, which can affect lung mechanics due to increased abdominal pressure and diaphragm movement. Participants are randomly assigned to one of three groups receiving different ventilation settings during surgery. The PCV-VG group receives a preset tidal volume with the lowest possible airway pressure. The PCV group has airway pressure adjusted to achieve a target volume, and the VCV group is set to a specific tidal volume. Respiratory rates are adjusted based on oxygen levels and carbon dioxide measurements. These methods aim to balance lung protection and adequate ventilation. Children aged 1 to 8 years having elective abdominal or urologic laparoscopic surgery will be monitored during surgery and shortly after. Researchers will measure lung compliance, oxygen and carbon dioxide levels, airway pressures, and tidal volumes at several time points before, during, and after the surgery. These measurements help assess how each ventilation mode affects lung function and gas exchange. The study is sponsored by Assiut University and will continue until early 2025.

CONDITIONS

Brief Title

PCV-VG in Pediatric Laparoscopic Surgery

Who Can Participate

Age: 1Year - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status I-II
  • Both sexes
  • Age between 1 and 8 years old
  • Scheduled for elective abdominal or urologic laparoscopic surgery
  • Body mass index between the 5th and 95th percentiles
Not Eligible

You will not qualify if you...

  • ASA physical status higher than II
  • Pre-existing lung disease
  • Pre-operative chest infection
  • Any thoracic deformities
  • Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level
  • Cardiac, hepatic, or renal diseases
  • Body mass index below the 5th or above the 95th percentile

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo pediatric laparoscopic surgery with mechanical ventilation using one of three ventilation modes according to their group allocation. Respiratory mechanics and ventilation parameters are monitored during surgery.

1 surgical procedure and monitoring during operation

Trial Site Locations

Total: 1 location

1

Assiut University Hospital

Asyut, Asyut Governorate, Egypt

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Research Team

M

Mahmoud M Khalil, MBBS

H

Hala S Abdel-Ghaffar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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