NCT01944254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

September 7, 2013

Last Update Submit

July 28, 2016

Conditions

Heart Diseases

Keywords

Cardiac surgical proceduresPulmonary Artery CatheterizationsCardiac outputSwan Ganz Catheterization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

random to respiration

ACTIVE COMPARATOR

Cardiac output measurement at random to respiration

Procedure: Cardiac output measurement at random to respiration

timed with expiration start

EXPERIMENTAL

Cardiac output measurement synchronised at start of expiration.

Procedure: Cardiac output measurement synchronised at start of expiration

timed to instructed exhalation

EXPERIMENTAL

Cardiac output measurement timed to instructed exhalation. The patient will receive instructions to exhale slowly using a peak expiratory flow (PEF)-flute and the cardiac output measurement will be started (i.e bolus given) at the start of expiration.

Procedure: Cardiac output measurement timed to instructed exhalation

Interventions

Cardiac output measurement at random to respirationPROCEDURE

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

random to respiration
Cardiac output measurement synchronised at start of expirationPROCEDURE

Cardiac output measurement obtained by PAC TD

timed with expiration start
Cardiac output measurement timed to instructed exhalationPROCEDURE

Cardiac output measurement obtained by PAC TD

timed to instructed exhalation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of circulation and medical imaging, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • Kjetsa 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.

    PMID: 26497869RESULT

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Idar Kirkeby-Garstad, Dr.

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2013

First Posted

September 17, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

NO(1)