The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.

The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.

This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Pressure Controlled Ventilation; Other: Volume Controlled Ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Medical Faculty of Cerrahpasa
    • Contact: Hacer Zeynep Turgut, MD; Phone Number: +905057859922; Email: drzturgut@gmail.com
    • Contact: Fatis Altintas, MD; Phone Number: +905337785278; Email: fatisaltintas@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria: 18-75 age

• Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
• Patient with ASA (American Society of Anesthesiologists) Score 1-3

Exclusion Criteria:

• Patients with ASA Score above 3
• Patients with obstructive (FEV1<%60) or restrictive pulmonary disease (FVC<%60)
• Patients with intrathoracic operation history
• Heavy smokers (>25 cigarettes/day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure Controlled Ventilation; Patients undergoing pressure controlled ventilation	Other: Pressure Controlled Ventilation; Patients will be ventilated with a pressure level which supplies a tidal volume corresponding 8ml/kg, 12 breaths per minute, 1/2 inspiration/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.
Active Comparator: Volume Controlled Ventilation; Patients undergoing volume controlled ventilation	Other: Volume Controlled Ventilation; Patients will be ventilated with a tidal volume which corresponds 8ml/kg, 12 breaths per minute, 1/2 inspirastion/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between LUS Scores at T5 in patients ventilated with VCV and PCV	Lung Ultrasonography will be applied to patients after surgery in the recovery room at T5. Two different groups' LUS scores will be calculated and compared.	(T5) 60 minutes after patients come to the recovery room.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between LUS Scores at T2 in patients ventilated with VCV and PCV	Lung Ultrasonography will be applied to patients after intubation. Two different groups' LUS scores will be calculated and compared.	(T2) 5 minutes after intubation
The difference between LUS Scores at T3 in patients ventilated with VCV and PCV	Lung Ultrasonography will be applied to patients at Trendelenburg position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.	(T3) 5 minutes after the surgical procedure is finished
The difference between LUS Scores at T4 in patients ventilated with VCV and PCV	Lung Ultrasonography will be applied to patients at supin position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.	(T4) 5 minutes after taking the patient to supin position

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Fatis Altintas, MD, Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; lung ultrasonography; volume controlled ventilation; pressure controlled ventilation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 68839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No