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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01892449
Enrollment
80
Registered
2013-07-04
Start date
2013-06-30
Completion date
2014-02-28
Last updated
2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia Using Endotracheal Intubation

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.

Interventions

OTHERprolonged 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.

OTHERconventional 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The peak inspiratory pressurebefore 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflationThe peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026