Assessment of Right Ventricular FunctionNCT05452044
A Comparison of Right Ventricular Function in the Apical and Subcostal 4 Chamber TTE Views in the Perioperative Setting
An observational study of Assessment of Right Ventricular Function, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The investigators would like to investigate whether angle-independent measurements of the heart's function can be made with the help of new computer programs and modern ultrasound devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of Right Ventricular Function
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jun 2022to Dec 2022
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery
Who may be able to join
- Consenting, adult, in-patients undergoing surgery
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, vulnerable population, illiterate populations, incompetent/incapacitated adults, -psychological disorders, dementia,
- Previous enrolment into the current study,
- Emergency procedures mandating expeditive patient care,
- Non regular heart rhythm
- Documented valvular heart disease in the RV at least midgrade
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4056
Eckhard Mauermann, Dr. med. MD, +4161 265 74 24, Eckhard.mauermann@gmail.com
About this study
Official title: A Comparison of Right Ventricular Function in the Apical 4 Chamber and Subcostal 4 Chamber TTE Views in the Perioperative Setting: A Prospective Clinical Study
The investigators would like to investigate whether angle-independent measurements of the heart's function can be made with the help of new computer programs and modern ultrasound devices. Furthermore, it will be checked whether and to what extent the patient's body position and general anesthesia have an influence on the ultrasound measurements.
Read the detailed description
Measuring right ventricular function is difficult on account of the ventricles shape, position, and mode of contraction. In transthoracic echocardiography a number of measures are endorsed by current guidelines, including: tricuspid annular plane systolic excursion (TAPSE), tricuspid annular plane velocities (S'), the right ventricular myocardial performance index (MPI), and fractional area change (FAC). Clinically, assessment is usually limited to measuring TAPSE by M-Mode or S' by tissue Doppler imaging, both of which are angle dependent technologies, but unlike the RV MPI or FAC are quick and easy to measure.
In the perioperative period, however, transthoracic echocardiography may be challenging for a number of reasons. First, obtaining usable apical 4-chamber (AP4C) images - the view used to measure TAPSE and S' - may be difficult in ventilated or post-surgical patients; subcostal 4-chamber views (SC4C), however, are generally obtainable. Secondly, gold standard images of the RV function are generally measured in the left lateral decubitus position, rather than supine, as is usually the case perioperative.
Newer technologies - such as speckle-tracking and 3D imaging - may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For example, speckle-tracking can also measure TAPSE and S' and 3D imaging has been shown to correlated very well with MRI, the gold-standard for volume measurements.
This study aims at examining the bias, precision, and reproducibility of speckle-tracking based TAPSE and S' (TAPSESTE and S'STE) measured in the SC4C with measurements of TAPSE by M-Mode and S' TDI (TAPSEM-MODE and S'TDI) in the left lateral decubitus position. Secondly, the investigators will compare measures of RV function made in the supine position to those in the left lateral decubitus position to ascertain the relevance of positioning in the perioperative setting. Patients will have measurements made before and after induction of anaesthesia.
The investigators hypothesize that TAPSE measured by STE in the SC4C with the patient in supine position(TAPSE STE, SC4C, Supine) will be sufficiently similar to TAPSE measured by M-MODE in the AP4C with the patient in the left lateral decubitus position (TAPSE MMODE, AP4C, LLD). A similar hypothesis holds for S' (S' STE, SC4C, Supine and S' TDI, AP4C, LLD).
- Conditions
- Assessment of Right Ventricular Function
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement TAPSE
Displacement (TAPSE) measured by:
TAPSE STE, SC4C, Supine TAPSE MMODE, AP4C, LLD
Measured: 25 minutes
Secondary outcomes (1)
Velocity (S')
TAPSE STE and TAPSEMMODE both in the AP4C, but supine vs. in left lateral decubitus position.
The effect of frame rate on S'STE measurements
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start8 Jun 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Right Ventricular FunctionStudies 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
- 51 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eckhard Mauermann, MD, M.Sc, Study director, University Hospital Basel Department for Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452044
- Sponsor's protocol ID
- ID 2020-02841
- Status last verified
- Dec 2022
- First submitted
- 18 May 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All measurements first are going to be written down on the CRF. After this we are going to enter the data in the system (Redcap®). All written CRF's are then stored in a locked room of the research groups for ten years. After every 10th patient an otherwise uninvolved study nurse will compare the datebase entry in RedCap, the CRF, and the source documents. If the findings are insufficient, more frequent checks will occur. Source docs are: premedication documentation, anesthesia record, echo measurement documentation (CRF). These will also be stored in the locked premises of the research group.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Right Ventricular Function in the Apical 4 Chamber and Subcostal 4 Chamber TTE Views in the Perioperative Setting: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05452044
- Acronym / sponsor ID
- ID 2020-02841
- Conditions
- Assessment of Right Ventricular Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Jul 2022 (actual)
- 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 would like to investigate whether angle-independent measurements of the heart's function can be made with the help of new computer programs and modern ultrasound devices. Furthermore, it will be checked whether and to what extent the patient's body position and general anesthesia have an influence on the ultrasound measurements.
Detailed description
Measuring right ventricular function is difficult on account of the ventricles shape, position, and mode of contraction. In transthoracic echocardiography a number of measures are endorsed by current guidelines, including: tricuspid annular plane systolic excursion (TAPSE), tricuspid annular plane velocities (S'), the right ventricular myocardial performance index (MPI), and fractional area change (FAC). Clinically, assessment is usually limited to measuring TAPSE by M-Mode or S' by tissue Doppler imaging, both of which are angle dependent technologies, but unlike the RV MPI or FAC are quick and easy to measure.
In the perioperative period, however, transthoracic echocardiography may be challenging for a number of reasons. First, obtaining usable apical 4-chamber (AP4C) images - the view used to measure TAPSE and S' - may be difficult in ventilated or post-surgical patients; subcostal 4-chamber views (SC4C), however, are generally obtainable. Secondly, gold standard images of the RV function are generally measured in the left lateral decubitus position, rather than supine, as is usually the case perioperative.
Newer technologies - such as speckle-tracking and 3D imaging - may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For example, speckle-tracking can also measure TAPSE and S' and 3D imaging has been shown to correlated very well with MRI, the gold-standard for volume measurements.
This study aims at examining the bias, precision, and reproducibility of speckle-tracking based TAPSE and S' (TAPSESTE and S'STE) measured in the SC4C with measurements of TAPSE by M-Mode and S' TDI (TAPSEM-MODE and S'TDI) in the left lateral decubitus position. Secondly, the investigators will compare measures of RV function made in the supine position to those in the left lateral decubitus position to ascertain the relevance of positioning in the perioperative setting. Patients will have measurements made before and after induction of anaesthesia.
The investigators hypothesize that TAPSE measured by STE in the SC4C with the patient in supine position(TAPSE STE, SC4C, Supine) will be sufficiently similar to TAPSE measured by M-MODE in the AP4C with the patient in the left lateral decubitus position (TAPSE MMODE, AP4C, LLD). A similar hypothesis holds for S' (S' STE, SC4C, Supine and S' TDI, AP4C, LLD).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery
Key inclusion criteria (1 listed)
- Consenting, adult, in-patients undergoing surgery
Key exclusion criteria (5 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, vulnerable population, illiterate populations, incompetent/incapacitated adults, -psychological disorders, dementia,
- Previous enrolment into the current study,
- Emergency procedures mandating expeditive patient care,
- Non regular heart rhythm
- Documented valvular heart disease in the RV at least midgrade
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
Displacement TAPSE
Time frame: 25 minutes
Displacement (TAPSE) measured by: TAPSE STE, SC4C, Supine TAPSE MMODE, AP4C, LLD
1 secondary outcome
Velocity (S')
Time frame: 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Declaration of HelsinkiLink provided by the sponsor.
- Individual participant dataSharing planned: No. All measurements first are going to be written down on the CRF. After this we are going to enter the data in the system (Redcap®). All written CRF's are then stored in a locked room of the research groups for ten years. After every 10th patient an otherwise uninvolved study nurse will compare the datebase entry in RedCap, the CRF, and the source documents. If the findings are insufficient, more frequent checks will occur. Source docs are: premedication documentation, anesthesia record, echo measurement documentation (CRF). These will also be stored in the locked premises of the research group.
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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.
Eckhard Mauermann, MD, M.Sc study director
University Hospital Basel Department for Anaesthesia
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 Assessment of Right Ventricular Function, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eckhard Mauermann, MD, M.Sc (+4161 265 74 24, Eckhard.mauermann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement TAPSE (time frame: 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.