The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

January 21, 2016 updated by: Ib Jammer, Haukeland University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pneumoperitoneum and SVV/PPV
Procedure: Pneumoperitoneum and SVV/PPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
peroperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1475/REK vest

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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