The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients

Comparison of the Precision of Cardiac Output-measures at Random to Respiration, Synchronised With Expiration and Instructed Slow Exhalation, Obtained by Pulmonal Artery Catheter Thermodilution Technique With Cold Injection

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01944254

Acronym

TEMP2

Enrollment

Registered

2013-09-17

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Cardiac surgical procedures, Pulmonary Artery Catheterizations, Cardiac output, Swan Ganz Catheterization

Brief summary

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.

Interventions

PROCEDURECardiac output measurement at random to respiration

Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)

PROCEDURECardiac output measurement synchronised at start of expiration

Cardiac output measurement obtained by PAC TD

PROCEDURECardiac output measurement timed to instructed exhalation

Cardiac output measurement obtained by PAC TD

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries, * informed and written consent to participation in the study in accordance with the Helsinki declaration * hemodynamic stability

Exclusion criteria

* Hemodynamical instability * atrial fibrillation * tricuspid insufficiency ≥ grade 2 * hemodialysis or other conditions where extra volume load can be negative, * lack of ability to give a written consent to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
The observed variance amongst the cardiac output measures	1 hour	The measures will be obtained the first postoperative morning by pulmonary artery catheter thermodilution technique. In total 24 measurements will be done in each patient, i.e 8 measurements in each interventional series described later. The variance observed will create the foundation for calculating the precision of the measures.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026