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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01868347
Acronym
OPERA
Enrollment
40
Registered
2013-06-04
Start date
2013-02-28
Completion date
2014-12-31
Last updated
2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Patients With Prostate Cancer Disease

Keywords

obese patients, specific elastance, Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy

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).

Interventions

OTHERtreatment

preemptive PEEP before pneumoperitoneum and trendelenburg

OTHERcontrol

PEEP after pneumoperitoneum and trendelenburg

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Chronic cardiac or pulmonary diseases

Design outcomes

Primary

MeasureTime frame
evaluation of arterial oxygenationat 6 hours (average duration of surgery procedure)

Secondary

MeasureTime frameDescription
evaluation of specific static elastance of the lungat 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 dioxideat 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

Other

MeasureTime frame
variation of gas exchange in post operative periodat 1 week (average duration)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026