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

Primary Purpose

Obese Patients With Prostate Cancer Disease

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
treatment
control
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese Patients With Prostate Cancer Disease focused on measuring obese patients, specific elastance, Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >= 30
  • Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

  • Chronic cardiac or pulmonary diseases

Sites / Locations

  • A.O.U San Luigi Gonzaga Hospital, Univesity of TurinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

Treatment

Arm Description

PEEP after pneumoperitoneum and trendelenburg

preemptive PEEP before pneumoperitoneum and trendelenburg

Outcomes

Primary Outcome Measures

evaluation of arterial oxygenation

Secondary Outcome Measures

evaluation of specific static elastance of the lung
Evaluation of the elastic properties of the lung (specific static elastance)
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

Full Information

First Posted
May 23, 2013
Last Updated
June 5, 2013
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01868347
Brief Title
Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Patients With Prostate Cancer Disease
Keywords
obese patients, specific elastance, Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
PEEP after pneumoperitoneum and trendelenburg
Arm Title
Treatment
Arm Type
Experimental
Arm Description
preemptive PEEP before pneumoperitoneum and trendelenburg
Intervention Type
Other
Intervention Name(s)
treatment
Intervention Description
preemptive PEEP before pneumoperitoneum and trendelenburg
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
PEEP after pneumoperitoneum and trendelenburg
Primary Outcome Measure Information:
Title
evaluation of arterial oxygenation
Time Frame
at 6 hours (average duration of surgery procedure)
Secondary Outcome Measure Information:
Title
evaluation of specific static elastance of the lung
Description
Evaluation of the elastic properties of the lung (specific static elastance)
Time Frame
at 6 hours (average duration of surgery procedure)
Title
evaluation of difference between arterial end-tidal partial pressure of carbon dioxide
Description
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
Time Frame
at 6 hours (average duration of surgery procedure)
Other Pre-specified Outcome Measures:
Title
variation of gas exchange in post operative period
Time Frame
at 1 week (average duration)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >= 30 Robotic-assisted laparoscopic prostatectomy Exclusion Criteria: Chronic cardiac or pulmonary diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Terragni, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Augusto Tempia, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
A.O.U San Luigi Gonzaga Hospital, Univesity of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Terragni, MD
Phone
+390116334002
Email
pierpaolo.terragni@unito.it
First Name & Middle Initial & Last Name & Degree
Pierpaolo Terragni, MD

12. IPD Sharing Statement

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

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