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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Obese Patients With Prostate Cancer Disease

Intervention / Treatment
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* Other: treatment
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >= 30 Robotic-assisted laparoscopic prostatectomy Exclusion Criteria: Chronic cardiac or pulmonary diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>PEEP after pneumoperitoneum and trendelenburg | Other: control<br>* PEEP after pneumoperitoneum and trendelenburg<br>|
| Experimental: Treatment<br>preemptive PEEP before pneumoperitoneum and trendelenburg | Other: treatment<br>* preemptive PEEP before pneumoperitoneum and trendelenburg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy, obese patients, specific elastance