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

NCT03740854 | Unknown DMC

• 1 other identifier: 68839
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

lung ultrasonography; mechanical ventilation; pressure controlled ventilation; volume controlled ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The difference between LUS Scores at T2 in patients ventilated with VCV and PCV

  (T2) 5 minutes after intubation

• The difference between LUS Scores at T3 in patients ventilated with VCV and PCV

  (T3) 5 minutes after the surgical procedure is finished

• The difference between LUS Scores at T4 in patients ventilated with VCV and PCV

  (T4) 5 minutes after taking the patient to supin position

Study Arms (2)

Pressure Controlled Ventilation

ACTIVE COMPARATOR

Patients undergoing pressure controlled ventilation

Other: Pressure Controlled Ventilation

Volume Controlled Ventilation

ACTIVE COMPARATOR

Patients undergoing volume controlled ventilation

Other: Volume Controlled Ventilation

Interventions

Pressure Controlled Ventilation OTHER

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.

Pressure Controlled Ventilation

Volume Controlled Ventilation OTHER

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.

Volume Controlled Ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Since our study will be performed in patients with prostate cancer, all of our patients will be male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Medical Faculty of Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Fatis Altintas, MD

  Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty

  STUDY DIRECTOR

Central Study Contacts

Hacer Zeynep Turgut, MD

CONTACT

+905057859922; drzturgut@gmail.com

Fatis Altintas, MD

CONTACT

+905337785278; fatisaltintas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 14, 2018
• Study Start: December 4, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

TU (1)