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

Heart Diseases Clinical Trial

— TEMP2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944254
• Other study ID #: 2013/409
• Status: Completed
• Phase: N/A
• First received: September 7, 2013
• Last updated: July 28, 2016
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Procedure:
• Cardiac output measurement at random to respiration
Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)
• Cardiac output measurement synchronised at start of expiration
Cardiac output measurement obtained by PAC TD
• Cardiac output measurement timed to instructed exhalation
Cardiac output measurement obtained by PAC TD

Locations

Country	Name	City	State
Norway	Department of circulation and medical imaging, NTNU	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Kjetså E, Skjaervold NK, Skogvoll E, Kirkeby-Garstad I. Synchronizing thermodilution cardiac output measurements with spontaneous breathing does not improve precision. Acta Anaesthesiol Scand. 2016 Mar;60(3):354-9. doi: 10.1111/aas.12650. Epub 2015 Oct 26 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The observed variance amongst the cardiac output measures	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.	1 hour	No