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

NCT ID: NCT01868347

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

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).

Conditions

Obese Patients With Prostate Cancer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

PEEP after pneumoperitoneum and trendelenburg

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

PEEP after pneumoperitoneum and trendelenburg

Treatment

preemptive PEEP before pneumoperitoneum and trendelenburg

Group Type: EXPERIMENTAL

treatment

Intervention Type: OTHER

preemptive PEEP before pneumoperitoneum and trendelenburg

Interventions

treatment

preemptive PEEP before pneumoperitoneum and trendelenburg

Intervention Type: OTHER

control

PEEP after pneumoperitoneum and trendelenburg

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI >= 30
• Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria

• Chronic cardiac or pulmonary diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

PierPaolo Terragni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierpaolo Terragni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Augusto Tempia, MD

Role: STUDY_CHAIR

University of Turin, Italy

Locations

A.O.U San Luigi Gonzaga Hospital, Univesity of Turin

Turin, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Pierpaolo Terragni, MD

Role: primary

pierpaolo.terragni@unito.it

+390116334002

Other Identifiers

CEI-20686

Identifier Type: -

Identifier Source: org_study_id