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

NCT ID: NCT03740854

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pressure Controlled Ventilation

Patients undergoing pressure controlled ventilation

Group Type ACTIVE_COMPARATOR

Pressure Controlled Ventilation

Intervention Type 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.

Volume Controlled Ventilation

Patients undergoing volume controlled ventilation

Group Type ACTIVE_COMPARATOR

Volume Controlled Ventilation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Hacer Zeynep Turgut

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatis Altintas, MD

Role: STUDY_DIRECTOR

Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty

Locations

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Medical Faculty of Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hacer Zeynep Turgut, MD

Role: CONTACT

+905057859922

Fatis Altintas, MD

Role: CONTACT

+905337785278

Facility Contacts

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Hacer Zeynep Turgut, MD

Role: primary

+905057859922

Fatis Altintas, MD

Role: backup

+905337785278

Other Identifiers

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68839

Identifier Type: -

Identifier Source: org_study_id

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