Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

Robot Assisted Laparoscopic Prostatectomy Clinical Trial

Official title:

Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202953
• Other study ID #: 4-2017-0400
• Status: Completed
• Phase: N/A
• Start date: July 4, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. adult (20-80 years old)

2. patients undergoing robot assisted laparoscopic prostatectomy

Exclusion Criteria:

1. history of COPD

2. decreased heart function (EF <50%)

3. BMI>30

4. patients who cannot read the consent form (e.g., blind, foreigner)

Related Conditions & MeSH terms

• Pneumoperitoneum
• Robot Assisted Laparoscopic Prostatectomy

Intervention

Procedure:
• ventilation strategy 1
In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV. Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.
• ventilation strategy 2
In group A, after trendelenburg position, patients will be applied autoflow VCV. - Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2	PaO2 analyzed by arterial blood gas analysis	30 minutes after trendelenburg position
Secondary	PaO2		10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Secondary	End tidal CO2		10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Secondary	peak airway pressure		10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Secondary	blood pressure		10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Secondary	Arterial blood gas analysis	pH, SaO2, Base excess	10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)