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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06117748
Collaborator
(none)
64
1
2
7.9
8.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pressure controlled ventilation-volume guaranteed
  • Other: Volume controlled ventilation
N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery
Actual Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group (PCV-VG): Pressure controlled ventilation-volume guaranteed

Patients will receive pressure controlled ventilation-volume guaranteed

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.

Other: Group (VCV): Volume controlled ventilation

Patients will receive Volume controlled ventilation

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.

Outcome Measures

Primary Outcome Measures

  1. Oxygenation index [Till the end of surgery]

    Oxygenation index =mean airway pressure × fraction of inspired oxygen (FiO2) × 100÷ Partial pressure of oxygen (PaO2)

Secondary Outcome Measures

  1. Mean arterial blood pressure [Till the end of surgery]

    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.

  2. Heart rate [Till the end of surgery]

    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.

  3. Oxygen saturation SpO2 [Till the end of surgery]

    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.

  4. Arterial PCo2 [Till the end of surgery]

    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).

  5. Lung compliance [Till the end of surgery]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Cairo Egypt 11591

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Maamoun Maamoun Soliman, Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Ain Shams University
ClinicalTrials.gov Identifier:
NCT06117748
Other Study ID Numbers:
  • MD 280 / 2022
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023