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Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

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ClinicalTrials.gov Identifier: NCT01892449
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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. 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.

Condition or disease Intervention/treatment Phase
General Anesthesia Using Endotracheal Intubation Other: prolonged inspiratory to expiratory (I:E) ratio (1:1) Other: conventional I:E ratio (1:2) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: prolonged I:E ratio (1:1) group Other: prolonged inspiratory to expiratory (I:E) ratio (1:1)
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.

Active Comparator: conventional I:E ratio (1:2) group Other: conventional I:E ratio (1:2)
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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892449


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University