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

Phase 3

• Conditions: Obese Patients With Prostate Cancer Disease
• Interventions: Other: treatment; Other: control

• Registration Number: NCT01868347
• Lead Sponsor: University of Turin, Italy

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).

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-04
• Last Update Submitted: 2013-06-05
• Last Update Posted: 2013-06-06
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• BMI >= 30
• Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria

• Chronic cardiac or pulmonary diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	treatment	preemptive PEEP before pneumoperitoneum and trendelenburg
control	control	PEEP after pneumoperitoneum and trendelenburg

Primary Outcome Measures

Name	Time	Method
evaluation of arterial oxygenation	at 6 hours (average duration of surgery procedure)

Secondary Outcome Measures

Name	Time	Method
evaluation of specific static elastance of the lung	at 6 hours (average duration of surgery procedure)	Evaluation of the elastic properties of the lung (specific static elastance)
evaluation of difference between arterial end-tidal partial pressure of carbon dioxide	at 6 hours (average duration of surgery procedure)	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

Trial Locations

Locations (1)

A.O.U San Luigi Gonzaga Hospital, Univesity of Turin; 🇮🇹 Turin, Italy