The Influence of Pneumoperitoneum on Minimal Invasive Car... | NCT01854307

Studies
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

NCT01854307

Sponsor

Haukeland University Hospital

Status

Terminated

Last Update Posted

Jan 25, 2016Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Pneumoperitoneum

Interventions

Pneumoperitoneum and SVV/PPV

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low inclusion rate

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Not provided

First Submitted Date

May 13, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2016

Last Update Posted Date

Jan 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumoperitoneum and SVV/PPV	Experimental		Procedure: Pneumoperitoneum and SVV/PPV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumoperitoneum and SVV/PPV	Procedure		Pneumoperitoneum and SVV/PPV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5021	Norway

Condition Browse Module

MeSH Terms

ID	Term
D011027	Pneumoperitoneum

Ancestor Terms

ID	Term
D010532	Peritoneal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided