Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-05

Study Completion Date

2024-07-01

Brief Summary

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The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position.

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Detailed Description

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Obesity, defined as a Body Mass Index (BMI) \>30 kg.m-2", is characterized by increased airway resistance, labored breathing and decreased respiratory system compliance. An increased rate of obese patients undergoing laparoscopic assisted surgery (LAS) is a health care concern due to anesthesia and ventilation difficulties in the obese population. Therefore, understanding the physiology and pathophysiology of lung function is an important issue during long-lasting LAS.

Carbon dioxide pneumoperitoneum with steep Trendelenburg positioning leads to a cranial displacement of the diaphragm and an increased volume of atelectasis, with a consequent decrease of total lung volume, lung compliance, and functional residual capacity. Thus, alleviation of increased airway pressure, improvement in oxygenation and CO2 elimination are the main goals during anesthetic management in laparoscopic assisted surgery.

In pressure controlled ventilation volume-guaranteed (PCV-VG) mode, the ventilator regulates the Peak Inspiratory Pressure (PIP) to achieve the optimal TV. To achieve the target volume, ventilator parameters are regularly changed without adjusting airway pressures. Hence, PCV-VG has the advantages of both Volume-Controlled Ventilation (VCV) and pressure controlled ventilation (PCV) to preserve the target minute ventilation while maintaining a low incidence of barotraumas.

PCV-VG is a type-controlled ventilation mode with a dual character as it has the criteria of both PCV and VCV. This recent ventilation mode which is one of the pressure regulated volume controlled (PRVC) that include Auto Flow ventilation, offers the ability to reduce the inspiratory pressure and as a result the incidence of barotrauma

Conditions

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Volume-Controlled Ventilation Pressure-Controlled Ventilation Volume Guaranteed Obese Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group (PCV-VG): Pressure controlled ventilation-volume guaranteed

Patients will receive pressure controlled ventilation-volume guaranteed

Group Type EXPERIMENTAL

Pressure controlled ventilation-volume guaranteed

Intervention Type OTHER

Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.

Respiratory parameters will be kept constant if ETCO2 is \<45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.

Group (VCV): Volume controlled ventilation

Patients will receive Volume controlled ventilation

Group Type OTHER

Volume controlled ventilation

Intervention Type OTHER

Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.

Respiratory parameters will be kept constant if ETCO2 is \<45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.

Interventions

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Pressure controlled ventilation-volume guaranteed

Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.

Respiratory parameters will be kept constant if ETCO2 is \<45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.

Intervention Type OTHER

Volume controlled ventilation

Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.

Respiratory parameters will be kept constant if ETCO2 is \<45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age: 16 - 60 years old.
2. Sex: both males and females.
3. Undergoing elective Laparoscopic Surgery.
4. Obese patient with Body Mass Index between ≥30 Kg/m2.
5. American society of Anesthesiologist (ASA) class I/ II.

Exclusion Criteria

1. Patient refusal.
2. American society of Anesthesiology (ASA) III or IV.
3. Intraoperative hemodynamic instability.
4. Patients with pulmonary hypertension.
5. Obese patients on home O2 therapy
6. Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
7. Anti-Trendelenburg position.
8. Asthmatic Patients.
9. Patients with advanced liver disease.
10. Patients with advanced renal disease.
11. Patients with advanced malignancy.
12. Pregnant females.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No