The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

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. Identifier: NCT01854307
Recruitment Status : Terminated (Low inclusion rate)
First Posted : May 15, 2013
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):
Ib Jammer, Haukeland University Hospital

Brief Summary:
Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.

Condition or disease Intervention/treatment Phase
Pneumoperitoneum Procedure: Pneumoperitoneum and SVV/PPV Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Study Start Date : May 2013
Actual Primary Completion Date : August 2015

Arm Intervention/treatment
Experimental: Pneumoperitoneum and SVV/PPV Procedure: Pneumoperitoneum and SVV/PPV

Primary Outcome Measures :
  1. Change of stroke volume variation and pulse pressure variation during pneumoperitoneum [ Time Frame: peroperative ]
    Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum.

Secondary Outcome Measures :
  1. Difference in measurements from different methods of minimal cardiac output monitoring. [ Time Frame: peroperative ]
  2. Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder) [ Time Frame: peroperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all patients >18 years scheduled for robot-assisted prostatectomy
  • able to give informed consent

Exclusion Criteria:

  • Patient with atrial fibrillation or other non-regular rhythm.
  • Severe aorta/mitral stenosis
  • Not able to give informed consent

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 identifier (NCT number): NCT01854307

Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital

Responsible Party: Ib Jammer, MD, Haukeland University Hospital Identifier: NCT01854307     History of Changes
Other Study ID Numbers: 2012/1475/REK vest
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Ib Jammer, Haukeland University Hospital:
Difference of
before and after

Additional relevant MeSH terms:
Peritoneal Diseases
Digestive System Diseases