Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: a Pilot Study

NCT03117673 | Unknown

• 1 other identifier: 1113/2017
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 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.

Conditions

Transesophageal Echocardiography

Keywords

right ventricular systolic pressure (RVSP); Transesophageal echocardiography

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)

Other: transesophageal echocardiography measurements

group 2

Patients with mild to moderate TI and elevated RVSP (\> 40mmHg) and mean PAP (\> 25mmHg)

Other: transesophageal echocardiography measurements

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)

Other: transesophageal echocardiography measurements

Interventions

transesophageal echocardiography measurements OTHER

transesophageal echocardiography will be done routinely during the procedure. We will do additional measurements of the maximal TR velocity

group 1; group 2; group 3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical university of vienna, General hospital of Vienna

Vienna, 1090, Austria

RECRUITING

Study Officials

• Ulrike Weber, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike Weber, MD

CONTACT

004340400; ulrike.weber@meduniwien.ac.at

Bruno Mora, M.D.

CONTACT

004340400; bruno.mora@meduniwien.ac.at

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

Locations

AU (1)