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NCT01854307 Clinical Trial

The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Pneumoperitoneum Clinical Trial

Official title:
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01854307
Other study ID # 2012/1475/REK vest
Secondary ID
Status Terminated
Phase N/A
First received May 13, 2013
Last updated January 21, 2016
Start date May 2013

Study information
Verified date January 2016
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Procedure:
• Pneumoperitoneum and SVV/PPV

Locations
Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. peroperative No
Secondary Difference in measurements from different methods of minimal cardiac output monitoring. peroperative No
Secondary Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder) peroperative No
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