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NCT Number: NCT01892449

Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation 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. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.

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Key information

Conditions

General Anesthesia Using Endotracheal Intubation

Age range

20 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, 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 (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion criteria

  • Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure
  • BMI > 30 kg/m 2

Treatment and study plan

prolonged inspiratory to expiratory (I:E) ratio (1:1)

Other

80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum.

conventional I:E ratio (1:2)

Other

80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum.

Primary outcomes

  1. The peak inspiratory pressure

    Time frame: before 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
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2013
Registry last updated
May 23, 2014

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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