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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01944254
Other study ID # 2013/409
Secondary ID
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


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
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