Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position

Obese Patients With Prostate Cancer Disease Clinical Trial

— OPERA  

Official title:

The Obese Patient in the Urologic Robotic Surgery: the Role of a Preemptive Ventilator Strategy and Partitioning to Contrast Pneumoperitoneum and Trendelenburg Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01868347
• Other study ID #: CEI-20686
• Status: Recruiting
• Phase: Phase 3
• First received: May 23, 2013
• Last updated: June 5, 2013
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.

Description:

RARP (robotic assisted radical prostatectomy) requires the induction of pneumoperitoneum and the trendelenburg position, causing increase in the intra-abdominal pressure and cephalic shift of the diaphragm, with consequent airway closure and collapse of the dependent regions of the lung.

Obese subjects present an increased risk of respiratory complications, caused not only by the surgical procedure itself, but also by the respiratory mechanics changes associated with the body mass. In obese patients we can observe higher values of lung and chest wall elastance, with reduction in ventilation-perfusion ratio.

The partitioning between lung and chest wall elastance can improve ventilatory setting and mechanics parameters of ventilation.

In every patient we will place, after anesthesia induction, a catheter to get esophageal and gastric pressure that represent pleural and abdominal pressure.

Ventilation will be conducted with a tidal volume of 8-10 ml/kg (IBW) and a respiratory rate adequate to maintain a physiological level of Pa CO2.

The preemptive strategy involves recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position in the treatment group, while the current procedure provides it afterwards (control group).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI >= 30

• Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

• Chronic cardiac or pulmonary diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese Patients With Prostate Cancer Disease
• Pneumoperitoneum

Intervention

Other:
• treatment
preemptive PEEP before pneumoperitoneum and trendelenburg
• control
PEEP after pneumoperitoneum and trendelenburg

Locations

Country	Name	City	State
Italy	A.O.U San Luigi Gonzaga Hospital, Univesity of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	variation of gas exchange in post operative period		at 1 week (average duration)	Yes
Primary	evaluation of arterial oxygenation		at 6 hours (average duration of surgery procedure)	No
Secondary	evaluation of specific static elastance of the lung	Evaluation of the elastic properties of the lung (specific static elastance)	at 6 hours (average duration of surgery procedure)	No
Secondary	evaluation of difference between arterial end-tidal partial pressure of carbon dioxide	difference between arterial end-tidal partial pressure of carbon dioxide is an indicator of lung collapse and reopening after open-lung PEEP, which in turn reduce dead space	at 6 hours (average duration of surgery procedure)	No