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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obese Patients With Prostate Cancer Disease
• Intervention / Treatment: Other: control; Other: treatment

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • A.O.U San Luigi Gonzaga Hospital, Univesity of Turin
    • Contact: Pierpaolo Terragni, MD; Phone Number: +390116334002; Email: pierpaolo.terragni@unito.it
    • Principal Investigator: Pierpaolo Terragni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• BMI >= 30
• Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

• Chronic cardiac or pulmonary diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; PEEP after pneumoperitoneum and trendelenburg	Other: control; PEEP after pneumoperitoneum and trendelenburg
Experimental: Treatment; preemptive PEEP before pneumoperitoneum and trendelenburg	Other: treatment; preemptive PEEP before pneumoperitoneum and trendelenburg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluation of arterial oxygenation	at 6 hours (average duration of surgery procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Time Frame
variation of gas exchange in post operative period	at 1 week (average duration)

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Pierpaolo Terragni, MD, University of Turin, Italy; Study Chair: Augusto Tempia, MD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): June 6, 2013
• Last Update Submitted That Met QC Criteria: June 5, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Prostatectomy; robotic surgery; obese patients; Trendelenburg Position; specific elastance
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: CEI-20686