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Trial record 97 of 671 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT01868347
Recruitment Status : Unknown
Verified May 2013 by PierPaolo Terragni, University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : June 4, 2013
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
PierPaolo Terragni, 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.

Condition or disease Intervention/treatment Phase
Obese Patients With Prostate Cancer Disease Other: treatment Other: control Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control
PEEP after pneumoperitoneum and trendelenburg
Other: control
PEEP after pneumoperitoneum and trendelenburg

Experimental: Treatment
preemptive PEEP before pneumoperitoneum and trendelenburg
Other: treatment
preemptive PEEP before pneumoperitoneum and trendelenburg




Primary Outcome Measures :
  1. evaluation of arterial oxygenation [ Time Frame: at 6 hours (average duration of surgery procedure) ]

Secondary Outcome Measures :
  1. evaluation of specific static elastance of the lung [ Time Frame: at 6 hours (average duration of surgery procedure) ]
    Evaluation of the elastic properties of the lung (specific static elastance)

  2. evaluation of difference between arterial end-tidal partial pressure of carbon dioxide [ Time Frame: 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


Other Outcome Measures:
  1. variation of gas exchange in post operative period [ Time Frame: at 1 week (average duration) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >= 30
  • Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

  • Chronic cardiac or pulmonary diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868347


Locations
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Italy
A.O.U San Luigi Gonzaga Hospital, Univesity of Turin Recruiting
Turin, Italy, 10126
Contact: Pierpaolo Terragni, MD    +390116334002    pierpaolo.terragni@unito.it   
Principal Investigator: Pierpaolo Terragni, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Pierpaolo Terragni, MD University of Turin, Italy
Study Chair: Augusto Tempia, MD University of Turin, Italy

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Responsible Party: PierPaolo Terragni, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01868347     History of Changes
Other Study ID Numbers: CEI-20686
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: May 2013
Keywords provided by PierPaolo Terragni, University of Turin, Italy:
obese patients
specific elastance
Trendelenburg Position
Pneumoperitoneum
robotic surgery
Prostatectomy
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases