Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

NCT02512120 | Withdrawn DMC

• 1 other identifier: Autoflow46
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Airway pressure

  Airway pressure will be measured under specified ventilation mode.

  4hours

Secondary Outcomes (1)

• Vital sign

  4hours

Other Outcomes (1)

• Arterial blood gas analysis

  4hours

Study Arms (2)

volume controlled ventilation

EXPERIMENTAL

Randomized 23 patients will be applied VCV during RALP.

Device: volume controlled ventilation

autoflow-volume controlled ventilation

ACTIVE COMPARATOR

Randomized 23 patients will be applied autoflow-VCV during RALP.

Device: autoflow-volume controlled ventilation

Interventions

volume controlled ventilation DEVICE

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.

volume controlled ventilation

autoflow-volume controlled ventilation DEVICE

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.

autoflow-volume controlled ventilation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age 19-65)
• American Society of Anesthesiology Classification I-III

You may not qualify if:

• cardiovascular disease, cerebrovascular disease, pulmonary disease
• over BMI 30

Sponsors & Collaborators

• Korea University Anam Hospital: lead

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

• Hye-Won Shin, MD, PhD

  Department of anesthesiology and pain medicine, Korea University Anam Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MD, PhD

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 30, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 27, 2016

Record last verified: 2016-04