Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: a Pilot Study
1 other identifier
observational
39
1 country
1
Brief Summary
Transesophageal echocardiography (TEE) plays an important role in intraoperative monitoring and can be used to estimate pulmonary artery pressures. An excellent correlation between right ventricular systolic pressure (RVSP) measured by right heart catheterization (RHC) and simultaneously estimated by transthoracic echocardiography is reported and also implemented into the current guidelines for the echocardiographic assessment of the right heart in adults by the American Society of Echocardiography. So far there are no studies evaluating RVSP measured by transesophageal echocardiography (TEE) and recommendations are unclear which transesophageal view is the best for calculation. We want to assess if there is a difference in the systolic pulmonary artery pressure measured invasively with a pulmonary artery catheter (PAC) and the calculated right ventricular systolic pressure (RVSP) using transesophageal echocardiography (TEE) in 3 different views: ME 4Ch, ME RV inflow-outflow, ME modified bicaval.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedOctober 20, 2017
October 1, 2017
2.7 years
April 6, 2017
October 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RVSP calculated from TEE measurements
Bias and precision of RVSP calculated from TEE measurements as compared to measured systolic pulmonary artery pressure with PAC
during routine transesophageal echocardiography examination
Secondary Outcomes (1)
Differences in bias and precision between patients with normal, and elevated mean PAP, and those with severe TI
during routine transesophageal echocardiography examination
Study Arms (3)
group 1
Patients with mild to moderate TI and normal RVSP (\< 40mmHg) and mean PAP (\< 25mmHg)
group 2
Patients with mild to moderate TI and elevated RVSP (\> 40mmHg) and mean PAP (\> 25mmHg)
group 3
Patients with severe TI (defined as Vena contracta \> or equal 7mm, reversed systolic hepatic vein flow, proximal isovelocity surface area (PISA) radius \> 9 mm, and very large central jet or eccentric wall impinging jet)
Interventions
transesophageal echocardiography will be done routinely during the procedure. We will do additional measurements of the maximal TR velocity
Eligibility Criteria
39 patients scheduled for cardiac operation in general anaesthesia divided in 3 groups (13 per group): I. Patients with mild to moderate TI and normal RVSP (\< 40mmHg) and mean PAP (\< 25mmHg) II. Patients with mild to moderate TI and elevated RVSP (\> 40mmHg) and mean PAP (\> 25mmHg) Patients with severe TI (defined as Vena contracta \> or equal 7mm, reversed systolic hepatic vein flow, proximal isovelocity surface area (PISA) radius \> 9 mm, and very large central jet or eccentric wall impinging jet)
You may qualify if:
- Elective cardiac surgery in general anaesthesia
- Transesophageal echocardiography (TEE) indicated
- Pulmonary artery catheter (PAC) indicated
You may not qualify if:
- Age \< 18 years
- Atrial fibrillation
- Declined informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical university of vienna, General hospital of Vienna
Vienna, 1090, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrike Weber, M.D.
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass.Prof.Dr.
Study Record Dates
First Submitted
April 6, 2017
First Posted
April 18, 2017
Study Start
May 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
October 20, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share