Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

NCT ID: NCT02803424

Last Updated: 2016-12-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-31

Brief Summary

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The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.

Detailed Description

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Conditions

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Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia

Keywords

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robot-assisted laparoscopic radical prostatectomy Autoflow trendelenburg position pneumoperitoneum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Volume controlled ventilation

During the steep trendelenburg position and pneumoperitoneum, volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2.

Group Type EXPERIMENTAL

Volume controlled ventilation

Intervention Type OTHER

During anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change.

Autoflow-volume controlled ventilation

During the steep trendelenburg position and pneumoperitoneum, Autoflow-volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2.

Group Type ACTIVE_COMPARATOR

Autoflow-volume controlled ventilation

Intervention Type OTHER

After tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again.

Interventions

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Volume controlled ventilation

During anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change.

Intervention Type OTHER

Autoflow-volume controlled ventilation

After tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again.

Intervention Type OTHER

Other Intervention Names

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VCV Autoflow-VCV

Eligibility Criteria

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Inclusion Criteria

1\. Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion Criteria

1. chronic obstructive respiratory diseases
2. heart failure
3. body mass index (BMI \>30 kg/m2)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.

Reference Type BACKGROUND
PMID: 25869025 (View on PubMed)

Other Identifiers

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4-2016-0311

Identifier Type: -

Identifier Source: org_study_id