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


Phase 3
18 Years
80 Years
Open (Enrolling)
Male
Obese Patients With Prostate Cancer Disease

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Trial Information

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


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).


Inclusion Criteria:



- BMI >= 30

- Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

- Chronic cardiac or pulmonary diseases

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

evaluation of arterial oxygenation

Outcome Time Frame:

at 6 hours (average duration of surgery procedure)

Safety Issue:

No

Principal Investigator

Pierpaolo Terragni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Turin

Authority:

Italy: National Institute of Health

Study ID:

CEI-20686

NCT ID:

NCT01868347

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Obese Patients With Prostate Cancer Disease
  • obese patients
  • specific elastance
  • Trendelenburg Position
  • Pneumoperitoneum
  • robotic surgery
  • Prostatectomy
  • Obesity
  • Pneumoperitoneum
  • Prostatic Neoplasms

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