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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
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumoperitoneum focused on measuring Difference of, measurements, before and after

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
May 13, 2013
Last Updated
January 21, 2016
Sponsor
Haukeland University Hospital
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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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