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

Obese Clinical Trial

Official title:

Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117748
• Other study ID #: MD 280 / 2022
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: Ahmed M Soliman, Master
• Phone: 00201066556377
• Email: ahmedmaamounmaamoun2013[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopy
• Obese
• Obesity

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index	Oxygenation index =mean airway pressure × fraction of inspired oxygen (FiO2) × 100÷ Partial pressure of oxygen (PaO2)	Till the end of surgery
Secondary	Mean arterial blood pressure	Mean arterial blood pressure (MAP) will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.	Till the end of surgery
Secondary	Heart rate	Heart rate (HR) will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.	Till the end of surgery
Secondary	Oxygen saturation SpO2	Oxygen saturation SpO2 will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.	Till the end of surgery
Secondary	Arterial PCo2	Arterial blood gases will be analyzed using a blood gas analyzer before anesthesia induction and every 10 minutes in the first hour for arterial oxygen tension (paO2) , arterial CO2 tension (paCO2).	Till the end of surgery
Secondary	Lung compliance	Lung mechanics readings included peak air way pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), dynamic and static compliance of the respiratory system will be recorded after intubation and every 10 minutes in the first hour	Till the end of surgery