Comparison of Cardiac Output Measured by Ultrasound Dilut... | NCT01616017

Studies
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique

NCT01616017

Sponsor

Transonic Systems Inc.

Status

Completed

Last Update Posted

May 27, 2016Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Cardiac Disease
Post Surgery Patients

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
R44HL061994	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 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

May 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

May 29, 2012

First Submission Date that Met QC Criteria

Jun 6, 2012

First Posted Date

Jun 11, 2012Estimated

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

May 25, 2016

Last Update Posted Date

May 27, 2016Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

Brief Summary

Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest in less invasive methods of measuring CO. This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution (COUD).

Detailed Description

Not provided

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

39Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare Cardiac Output Measurements	To compare CO measured by ultrasound dilution method (COUD) and pulmonary artery thermodilution technique (COTD) in SICU (Surgical Intensive Care Unit) patients.	During the stay in the ICU with in situ catheters (expected avg 3 days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years of age
Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Exclusion Criteria:

Age < 18 years of age
Patients with structurally abnormal heart (e.g. shunt) (confirmed by history taking)
Patients who have heparin allergy. (Confirmed by history taking)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Age ≥ 18 years of age Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Queen's Medical Center		Honolulu	Hawaii	96813	United States