The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Primary Purpose
Pneumoperitoneum
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pneumoperitoneum and SVV/PPV
Sponsored by
About this trial
This is an interventional health services research trial for Pneumoperitoneum focused on measuring Difference of, measurements, before and after
Eligibility 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
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pneumoperitoneum and SVV/PPV
Arm Description
Outcomes
Primary Outcome Measures
Change of stroke volume variation and pulse pressure variation during pneumoperitoneum
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.
Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)
Full Information
NCT ID
NCT01854307
First Posted
May 13, 2013
Last Updated
January 21, 2016
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01854307
Brief Title
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Official Title
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Low inclusion rate
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum
Keywords
Difference of, measurements, before and after
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pneumoperitoneum and SVV/PPV
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum and SVV/PPV
Primary Outcome Measure Information:
Title
Change of stroke volume variation and pulse pressure variation during pneumoperitoneum
Description
Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum.
Time Frame
peroperative
Secondary Outcome Measure Information:
Title
Difference in measurements from different methods of minimal cardiac output monitoring.
Time Frame
peroperative
Title
Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)
Time Frame
peroperative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
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The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
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