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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pressure Controlled Ventilation
Volume Controlled Ventilation
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring lung ultrasonography, mechanical ventilation, pressure controlled ventilation, volume controlled ventilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical Faculty of CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pressure Controlled Ventilation

Volume Controlled Ventilation

Arm Description

Patients undergoing pressure controlled ventilation

Patients undergoing volume controlled ventilation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 12, 2018
Last Updated
February 26, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03740854
Brief Title
The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.
Official Title
The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
lung ultrasonography, mechanical ventilation, pressure controlled ventilation, volume controlled ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure Controlled Ventilation
Arm Type
Active Comparator
Arm Description
Patients undergoing pressure controlled ventilation
Arm Title
Volume Controlled Ventilation
Arm Type
Active Comparator
Arm Description
Patients undergoing volume controlled ventilation
Intervention Type
Other
Intervention Name(s)
Pressure Controlled Ventilation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Volume Controlled Ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference between LUS Scores at T5 in patients ventilated with VCV and PCV
Description
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.
Time Frame
(T5) 60 minutes after patients come to the recovery room.
Secondary Outcome Measure Information:
Title
The difference between LUS Scores at T2 in patients ventilated with VCV and PCV
Description
Lung Ultrasonography will be applied to patients after intubation. Two different groups' LUS scores will be calculated and compared.
Time Frame
(T2) 5 minutes after intubation
Title
The difference between LUS Scores at T3 in patients ventilated with VCV and PCV
Description
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.
Time Frame
(T3) 5 minutes after the surgical procedure is finished
Title
The difference between LUS Scores at T4 in patients ventilated with VCV and PCV
Description
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.
Time Frame
(T4) 5 minutes after taking the patient to supin position

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Since our study will be performed in patients with prostate cancer, all of our patients will be male.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hacer Zeynep Turgut, MD
Phone
+905057859922
Email
drzturgut@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatis Altintas, MD
Phone
+905337785278
Email
fatisaltintas@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatis Altintas, MD
Organizational Affiliation
Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Medical Faculty of Cerrahpasa
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hacer Zeynep Turgut, MD
Phone
+905057859922
Email
drzturgut@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatis Altintas, MD
Phone
+905337785278
Email
fatisaltintas@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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