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

U

University of Turin

Status and phase

Unknown
Phase 3

Conditions

Obese Patients With Prostate Cancer Disease

Treatments

Other: treatment
Other: control

Study type

Interventional

Funder types

Other

Identifiers

NCT01868347
CEI-20686

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI >= 30
  • Robotic-assisted laparoscopic prostatectomy

Exclusion criteria

  • Chronic cardiac or pulmonary diseases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

control
Active Comparator group
Description:
PEEP after pneumoperitoneum and trendelenburg
Treatment:
Other: control
Treatment
Experimental group
Description:
preemptive PEEP before pneumoperitoneum and trendelenburg
Treatment:
Other: treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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