Changes in Cardiac OutputNCT02070861
Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis
A study testing Ventricular pacing and passive leg raise in people with Changes in Cardiac Output, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Changes in Cardiac Output
- What is being tested?
- Ventricular pacing and passive leg raise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Jun 2015
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.
Who cannot join
- Esophageal pathology, EF <40%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)
The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.
The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.
Read the detailed description
Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.
- Conditions
- Changes in Cardiac Output
- Being tested
- Ventricular pacing and passive leg raise
- Keywords
- Cardiac output, Exhaled CO2, Nexfin, Esophageal Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular pacing and passive leg raiseOther
Ventricular pacing and passive leg raise
| Study group | Role | What they receive |
|---|---|---|
| Comparing cardiac output changes | Experimental | Explore the relationship between changes in cardiac output measured with eosophagal Doppler, the volume-clamp-method and exhaled CO2 during ventricular pacing and passive leg raise.
Measurements with the volume-clamp-method were aborted due to technological difficulties. Receives: Other: Ventricular pacing and passive leg raise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac output
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
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 Changes in Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Air Ambulance Foundation
- Responsible party
- Principal investigator, Ingrid Elise Hoff, Oslo University Hospital
- Investigators
- Leiv Arne Rosseland, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070861
- Sponsor's protocol ID
- 2013/1605
- Status last verified
- Apr 2018
- First submitted
- 23 Feb 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Publications
Hoff IE, Hoiseth LO, Kirkeboen KA, Landsverk SA. Volumetric and End-Tidal Capnography for the Detection of Cardiac Output Changes in Mechanically Ventilated Patients Early after Open Heart Surgery. Crit Care Res Pract. 2019 May 30;2019:6393649. doi: 10.1155/2019/6393649. eCollection 2019.
PubMed 31281675
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)
- ClinicalTrials.gov ID
- NCT02070861
- Acronym / sponsor ID
- 2013/1605
- Conditions
- Changes in Cardiac Output
- Keywords
- Cardiac output, Exhaled CO2, Nexfin, Esophageal Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Norwegian Air Ambulance Foundation
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Feb 2014 (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 investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.
The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.
Detailed description
Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparing cardiac output changes | Experimental | Other: Ventricular pacing and passive leg raiseExplore the relationship between changes in cardiac output measured with eosophagal Doppler, the volume-clamp-method and exhaled CO2 during ventricular pacing and passive leg raise. Measurements with the volume-clamp-method were aborted due to technological difficulties. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.
Key exclusion criteria (1 listed)
- Esophageal pathology, EF <40%
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 |
|---|---|---|
| Ventricular pacing and passive leg raiseVentricular pacing and passive leg raise | Other | Comparing cardiac output changes |
Primary outcome
Changes in cardiac output
Time frame: 5 Minutes
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 17 Apr 2018.
- Derived from this study: PubMed 31281675Hoff IE, Hoiseth LO, Kirkeboen KA, Landsverk SA. Volumetric and End-Tidal Capnography for the Detection of Cardiac Output Changes in Mechanically Ventilated Patients Early after Open Heart Surgery. Crit Care Res Pract. 2019 May 30;2019:6393649. doi: 10.1155/2019/6393649. eCollection 2019.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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.
Leiv Arne Rosseland, MD, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventricular pacing and passive leg raise in people with Changes in Cardiac Output, run by Oslo University Hospital 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 1 inclusion and 1 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 17 Apr 2018. 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?
Changes in cardiac output (time frame: 5 Minutes). 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 NCT02070861, 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 17 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.