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

NCT02803424 | Completed DMC

• 1 other identifier: 4-2016-0311
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia

Keywords

robot-assisted laparoscopic radical prostatectomy; Autoflow; trendelenburg position; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

• arterial oxygen tension (PaO2)

  Arterial oxygen tension (PaO2) obtained from arterial blood gas analysis

  30 minutes after steep trendelenburg position and pneumoperitoneum.

Secondary Outcomes (1)

• The peak inspiratory pressure

  10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.

Study Arms (2)

Volume controlled ventilation

EXPERIMENTAL

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.

Other: Volume controlled ventilation

Autoflow-volume controlled ventilation

ACTIVE COMPARATOR

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.

Other: Autoflow-volume controlled ventilation

Interventions

Volume controlled ventilation 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.

Also known as: VCV

Volume controlled ventilation

Autoflow-volume controlled ventilation 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.

Also known as: Autoflow-VCV

Autoflow-volume controlled ventilation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• chronic obstructive respiratory diseases
• heart failure
• body mass index (BMI \>30 kg/m2)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25869025 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)