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Trial record 97 of 680 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 23, 2013
First Posted Date  ICMJE June 4, 2013
Last Update Posted Date June 6, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
evaluation of arterial oxygenation [ Time Frame: at 6 hours (average duration of surgery procedure) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01868347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 29, 2013)
variation of gas exchange in post operative period [ Time Frame: at 1 week (average duration) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position
Official Title  ICMJE The Obese Patient in the Urologic Robotic Surgery: the Role of a Preemptive Ventilator Strategy and Partitioning to Contrast Pneumoperitoneum and Trendelenburg Position
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obese Patients With Prostate Cancer Disease
Intervention  ICMJE
  • Other: treatment
    preemptive PEEP before pneumoperitoneum and trendelenburg
  • Other: control
    PEEP after pneumoperitoneum and trendelenburg
Study Arms  ICMJE
  • Active Comparator: control
    PEEP after pneumoperitoneum and trendelenburg
    Intervention: Other: control
  • Experimental: Treatment
    preemptive PEEP before pneumoperitoneum and trendelenburg
    Intervention: Other: treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI >= 30
  • Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

  • Chronic cardiac or pulmonary diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868347
Other Study ID Numbers  ICMJE CEI-20686
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PierPaolo Terragni, University of Turin, Italy
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierpaolo Terragni, MD University of Turin, Italy
Study Chair: Augusto Tempia, MD University of Turin, Italy
PRS Account University of Turin, Italy
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP