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Completed

NCT Number: NCT02803424

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

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.

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Key information

Conditions

Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: VCV

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.

Other names: Autoflow-VCV

Primary outcomes

  1. arterial oxygen tension (PaO2)

    Time frame: 30 minutes after steep trendelenburg position and pneumoperitoneum.

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

Secondary outcomes

  1. The peak inspiratory pressure

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

    The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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