Study on the Repeatability of Cardiac Output Measurements... | NCT00464750

Studies
Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate

NCT00464750

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 18, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Heart Diseases

Interventions

Pulmonary artery catheter

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Apr 23, 2007

First Submission Date that Met QC Criteria

Apr 23, 2007

First Posted Date

Apr 24, 2007Estimated

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

Jul 15, 2016

Last Update Posted Date

Jul 18, 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

This study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. In accordance with our clinical practice, thermal indicator injections are synchronized with respiration. The impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.

Detailed Description

Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. Recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision.

This study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. The reliability of the thermodilution measurements are tested A) in sedated, artificially ventilated cardiac surgical patients and B) in the same patients when postoperatively awake and spontaneously breathing. We further compare the use of room temperature and iced thermal indicator injections.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients.

Only patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary artery catheter	Device	Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.		Baxter

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria -

Exclusion Criteria:

Acute cardiac surgery
Preoperative arrythmias

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Elective patients for cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Idar Kirkeby-Garstad, MD, Ph D	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olav University Hospital		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25976600	Result	Kirkeby-Garstad I, Tronnes H, Stenseth R, Sellevold OF, Aadahl P, Skogvoll E. The Precision of Pulmonary Artery Catheter Bolus Thermodilution Cardiac Output Measurements Varies With the Clinical Situation. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):881-8. doi: 10.1053/j.jvca.2014.12.016. Epub 2014 Dec 12.