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OpenTrials
Completed

NCT Number: NCT01944254

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

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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of circulation and medical imaging, NTNU

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac output measurement at random to respiration

Procedure

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

Cardiac output measurement synchronised at start of expiration

Procedure

Cardiac output measurement obtained by PAC TD

Cardiac output measurement timed to instructed exhalation

Procedure

Cardiac output measurement obtained by PAC TD

Primary outcomes

  1. The observed variance amongst the cardiac output measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: TEMP2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2013
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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