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

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ClinicalTrials.gov Identifier: NCT03740854
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hacer Zeynep Turgut, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Pressure Controlled Ventilation Other: Volume Controlled Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The difference between LUS Scores at T5 in patients ventilated with VCV and PCV [ Time Frame: (T5) 60 minutes after patients come to the recovery room. ]
    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 :
  1. The difference between LUS Scores at T2 in patients ventilated with VCV and PCV [ Time Frame: (T2) 5 minutes after intubation ]
    Lung Ultrasonography will be applied to patients after intubation. Two different groups' LUS scores will be calculated and compared.

  2. The difference between LUS Scores at T3 in patients ventilated with VCV and PCV [ Time Frame: (T3) 5 minutes after the surgical procedure is finished ]
    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.

  3. The difference between LUS Scores at T4 in patients ventilated with VCV and PCV [ Time Frame: (T4) 5 minutes after taking the patient to supin position ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since our study will be performed in patients with prostate cancer, all of our patients will be male.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740854


Contacts
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Contact: Hacer Zeynep Turgut, MD +905057859922 drzturgut@gmail.com
Contact: Fatis Altintas, MD +905337785278 fatisaltintas@hotmail.com

Locations
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Turkey
Medical Faculty of Cerrahpasa Recruiting
Istanbul, Turkey
Contact: Hacer Zeynep Turgut, MD    +905057859922    drzturgut@gmail.com   
Contact: Fatis Altintas, MD    +905337785278    fatisaltintas@yahoo.com   
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Fatis Altintas, MD Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty

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Responsible Party: Hacer Zeynep Turgut, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT03740854     History of Changes
Other Study ID Numbers: 68839
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hacer Zeynep Turgut, Istanbul University:
lung ultrasonography
mechanical ventilation
pressure controlled ventilation
volume controlled ventilation