NCT01854307

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

May 13, 2013

Last Update Submit

January 21, 2016

Conditions

Pneumoperitoneum

Keywords

Difference ofmeasurementsbefore and after

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Difference in measurements from different methods of minimal cardiac output monitoring.

    peroperative

  • Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)

    peroperative

Study Arms (1)

Pneumoperitoneum and SVV/PPV

EXPERIMENTAL
Procedure: Pneumoperitoneum and SVV/PPV

Interventions

Pneumoperitoneum and SVV/PPVPROCEDURE
Pneumoperitoneum and SVV/PPV

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients \>18 years scheduled for robot-assisted prostatectomy
  • able to give informed consent

You may not qualify if:

  • Patient with atrial fibrillation or other non-regular rhythm.
  • Severe aorta/mitral stenosis
  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 15, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

NO(1)