Clinical trial NCT01868347: Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obese Patients With Prostate Cancer Disease
Keywords: obese patients
specific elastance
Trendelenburg Position
Pneumoperitoneum
robotic surgery
Prostatectomy
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* BMI \>= 30
* Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

* Chronic cardiac or pulmonary diseases

Primary outcomes:
measure: evaluation of arterial oxygenation
timeFrame: at 6 hours (average duration of surgery procedure)
Secondary outcomes:
measure: evaluation of specific static elastance of the lung
timeFrame: at 6 hours (average duration of surgery procedure)
measure: evaluation of difference between arterial end-tidal partial pressure of carbon dioxide
timeFrame: at 6 hours (average duration of surgery procedure)
Other outcomes:
measure: variation of gas exchange in post operative period
timeFrame: at 1 week (average duration)
Locations:
city: Turin
country: Italy
facility: A.O.U San Luigi Gonzaga Hospital, Univesity of Turin
Study officials:
affiliation: University of Turin, Italy
name: Pierpaolo Terragni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Augusto Tempia, MD
role: STUDY_CHAIR
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