Heart DiseasesNCT02820727
Perioperative Three Dimensional Right Ventricular Function
An observational study of Heart Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Diseases
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Nov 2016
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cardiac surgical patients
Who may be able to join
- informed consent given
- cardiac surgical procedure
- left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation
Who cannot join
- pregnant patients
- contraindication for transesophageal echocardiography
Trial locations and contacts
1 site in 1 country.
About this study
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.
- Conditions
- Heart Diseases
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on Intensive Care Unit (ICU)
Duration of ICU stay
Measured: up to 60 days
Secondary outcomes (5)
Time to hospital discharge
Hospital Outcome
Measured: up to 120 days
Catecholamine dosages
after anesthesia induction, end of surgery, 12h and 24h after intensive care unit (ICU) admission
Measured: up to 24 hours
Catecholamine free days
Catecholamine free days on ICU
Measured: up to 60 days
Hours on mechanical ventilation
Duration of mechanical ventilation
Measured: up to 1440 hours
Organ failure during ICU stay
Early organ failure (Lab tests: Creatinine, Bilirubin, Lactate, Thromboplastin Time)
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Magunia, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820727
- Sponsor's protocol ID
- AnTubingen-RV
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Magunia H, Jordanow A, Keller M, Rosenberger P, Nowak-Machen M. The effects of anesthesia induction and positive pressure ventilation on right-ventricular function: an echocardiography-based prospective observational study. BMC Anesthesiol. 2019 Nov 4;19(1):199. doi: 10.1186/s12871-019-0870-z.
PubMed 31684877
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Three Dimensional Right Ventricular Function
- ClinicalTrials.gov ID
- NCT02820727
- Acronym / sponsor ID
- AnTubingen-RV
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Jul 2016 (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.
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cardiac surgical patients
Key inclusion criteria (3 listed)
- informed consent given
- cardiac surgical procedure
- left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation
Key exclusion criteria (2 listed)
- pregnant patients
- contraindication for transesophageal echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time on Intensive Care Unit (ICU)
Time frame: up to 60 days
Duration of ICU stay
5 secondary outcomes
Time to hospital discharge
Time frame: up to 120 days
Catecholamine dosages
Time frame: up to 24 hours
Catecholamine free days
Time frame: up to 60 days
Hours on mechanical ventilation
Time frame: up to 1440 hours
Organ failure during ICU stay
Time frame: up to 60 days
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 16 Jul 2018.
- Derived from this study: PubMed 31684877Magunia H, Jordanow A, Keller M, Rosenberger P, Nowak-Machen M. The effects of anesthesia induction and positive pressure ventilation on right-ventricular function: an echocardiography-based prospective observational study. BMC Anesthesiol. 2019 Nov 4;19(1):199. doi: 10.1186/s12871-019-0870-z.
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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.
Harry Magunia, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by University Hospital Tuebingen at 1 site in Germany.
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 2 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 16 Jul 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 Germany. 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?
Time on Intensive Care Unit (ICU) (time frame: up to 60 days). 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 NCT02820727, 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 16 Jul 2018.