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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740854
• Other study ID #: 68839
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2019
• Source: Istanbul University
• Contact: Hacer Zeynep Turgut, MD
• Phone: +905057859922
• Email: drzturgut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Medical Faculty of Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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