Heart DiseasesTEMP2NCT01944254
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
A study testing Cardiac output measurement at random to respiration, Cardiac output measurement synchronised at start of expiration and Cardiac output measurement timed to instructed exhalation in people with Heart Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Cardiac output measurement at random to respiration, Cardiac output measurement synchronised at start of expiration and Cardiac output measurement timed to instructed exhalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Heart Diseases
- Being tested
- Cardiac output measurement at random to respiration, Cardiac output measurement synchronised at start of expiration, Cardiac output measurement timed to instructed exhalation
- Keywords
- Cardiac surgical procedures, Pulmonary Artery Catheterizations, Cardiac output, Swan Ganz Catheterization
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac output measurement at random to respirationProcedure or surgery
Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)
Cardiac output measurement synchronised at start of expirationProcedure or surgery
Cardiac output measurement obtained by PAC TD
Cardiac output measurement timed to instructed exhalationProcedure or surgery
Cardiac output measurement obtained by PAC TD
| Study group | Role | What they receive |
|---|---|---|
| random to respiration | Active comparator | Cardiac output measurement at random to respiration Receives: Procedure: Cardiac output measurement at random to respiration |
| timed with expiration start | Experimental | Cardiac output measurement synchronised at start of expiration. Receives: 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. Receives: Procedure: Cardiac output measurement timed to instructed exhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Idar Kirkeby-Garstad, Dr., Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944254
- Sponsor's protocol ID
- 2013/409
- Acronym
- TEMP2
- Status last verified
- Jul 2016
- First submitted
- 7 Sep 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26497869
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01944254
- Acronym / sponsor ID
- TEMP2 / 2013/409
- Conditions
- Heart Diseases
- Keywords
- Cardiac surgical procedures, Pulmonary Artery Catheterizations, Cardiac output, Swan Ganz Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| random to respiration | Active comparator | Procedure: Cardiac output measurement at random to respirationCardiac output measurement at random to respiration |
| timed with expiration start | Experimental | Procedure: Cardiac output measurement synchronised at start of expirationCardiac output measurement synchronised at start of expiration. |
| timed to instructed exhalation | Experimental | Procedure: Cardiac output measurement timed to instructed exhalationCardiac 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac output measurement at random to respirationCardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD) | Procedure or surgery | random to respiration |
| Cardiac output measurement synchronised at start of expirationCardiac output measurement obtained by PAC TD | Procedure or surgery | timed with expiration start |
| Cardiac output measurement timed to instructed exhalationCardiac output measurement obtained by PAC TD | Procedure or surgery | timed to instructed exhalation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Results publication: PubMed 26497869Kjetsa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idar Kirkeby-Garstad, Dr. principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac output measurement at random to respiration, Cardiac output measurement synchronised at start of expiration and Cardiac output measurement timed to instructed exhalation in people with Heart Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The observed variance amongst the cardiac output measures (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.