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The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Ib Jammer, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01854307
First received: May 13, 2013
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention
Pneumoperitoneum
Procedure: Pneumoperitoneum and SVV/PPV

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Change of stroke volume variation and pulse pressure variation during pneumoperitoneum [ Time Frame: peroperative ] [ Designated as safety issue: No ]
    Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum.


Secondary Outcome Measures:
  • Difference in measurements from different methods of minimal cardiac output monitoring. [ Time Frame: peroperative ] [ Designated as safety issue: No ]
  • Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder) [ Time Frame: peroperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumoperitoneum and SVV/PPV Procedure: Pneumoperitoneum and SVV/PPV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854307

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Ib Jammer       ib.jammer@helse-bergen.no   
Principal Investigator: Elin Aakre, MD         
Sub-Investigator: Gro Østgaard, MD, PhD         
Sub-Investigator: Ole Kristian Ulveseth, MD         
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Ib Jammer, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01854307     History of Changes
Other Study ID Numbers: 2012/1475/REK vest
Study First Received: May 13, 2013
Last Updated: May 14, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Difference of
measurements
before and after

Additional relevant MeSH terms:
Pneumoperitoneum
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on November 23, 2014