Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

Prostate Cancer Clinical Trial

— VCVAFVCV  

Official title:

Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02512120
• Other study ID #: Autoflow46
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2015
• Last updated: April 26, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Description:

Robot assisted laparoscopic radical prostatectomy(RALP) has been used to treatment of prostate cancer since 2001. RALP offers some advantage such as reduced blood loss, sparing nerves, less postoperative pain. However, RALP require steep Trendelenberg position with pneumoperitoneum. It can cause increased airway peak pressure and unwanted hemodynamic effect under conventional volume controlled ventilation(VCV). Autoflow-VCV use decelerating flow, can reduce airway peak pressure and improve dynamic compliance.

We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult (age 19-65)

• American Society of Anesthesiology Classification I-III

Exclusion Criteria:

• cardiovascular disease, cerebrovascular disease, pulmonary disease

• over BMI 30

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• volume controlled ventilation
After induction of anesthesia and intubation, patients will be applied VCV by Zeus®(Dräger, Germany). - Tidal volume : 8ml/kg(ieal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.
• autoflow-volume controlled ventilation
After induction of anesthesia and intubation, patients will be applied autoflow- VCV by Zeus®(Dräger, Germany). - Tidal volume : 8ml/kg(ideal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial blood gas analysis	Arterial blood gas analysis will be measured under specified ventilation mode.	4hours	No
Primary	Airway pressure	Airway pressure will be measured under specified ventilation mode.	4hours	No
Secondary	Vital sign	Vital sign will be measured under specified ventilation mode.	4hours	No