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

NCT06117748 | Unknown

• 1 other identifier: MD 280 / 2022
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Oxygenation index

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

  Till the end of surgery

Secondary Outcomes (5)

• Mean arterial blood pressure

  Till the end of surgery

• Heart rate

  Till the end of surgery

• Oxygen saturation SpO2

  Till the end of surgery

• Arterial PCo2

  Till the end of surgery

• Lung compliance

  Till the end of surgery

Study Arms (2)

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

EXPERIMENTAL

Patients will receive pressure controlled ventilation-volume guaranteed

Other: Pressure controlled ventilation-volume guaranteed

Group (VCV): Volume controlled ventilation

OTHER

Patients will receive Volume controlled ventilation

Other: Volume controlled ventilation

Interventions

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

Volume controlled ventilation 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

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patient refusal.
• American society of Anesthesiology (ASA) III or IV.
• Intraoperative hemodynamic instability.
• Patients with pulmonary hypertension.
• Obese patients on home O2 therapy
• Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
• Anti-Trendelenburg position.
• Asthmatic Patients.
• Patients with advanced liver disease.
• Patients with advanced renal disease.
• Patients with advanced malignancy.
• Pregnant females.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed M Soliman, Master

CONTACT

00201066556377; ahmedmaamounmaamoun2013@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 5, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)