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

Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803424
• Other study ID #: 4-2016-0311
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: December 25, 2016
• Start date: June 2016
• Est. completion date: December 2016

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Pneumoperitoneum
• Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia

Intervention

Other:
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial oxygen tension (PaO2)	Arterial oxygen tension (PaO2) obtained from arterial blood gas analysis	30 minutes after steep trendelenburg position and pneumoperitoneum.	No
Secondary	The peak inspiratory pressure	The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia	10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.	No