Intraoperative Diastolic Function by TDI and STE

NCT03088943 | Completed

• 1 other identifier: 2016/1550
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims at exploring measures of diastolic function perioperatively.

Conditions

Echocardiography, Doppler; Echocardiography, Three-Dimensional; Echocardiography, Transesophageal; Echocardiography, Transthoracic

Outcome Measures

Primary Outcomes (1)

• mean early diastolic mitral annular plane velocity (E')

  (E'lateral + E'medial)/2; by TDI and STE

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

Secondary Outcomes (10)

• mean late (atrial) diastolic mitral annular plane velocity (A')

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

• mean early diastolic mitral annular plane velocity/mean late (atrial) diastolic mitral annular plane velocity (E'/A')

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

• mean early diastolic mitral inflow velocity/mean early diastolic mitral annular plane velocities; (E/E')

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

• Peak systolic mitral annular velocity (S')

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

• Displacement by Mitral Annular Plane Systolic Excursion (MAPSE)

  immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

Study Arms (3)

TTE Apical 4 Chamber View

OTHER

Patients will receive TTE apical 4chamber echo examinations prior to induction and after induction

Other: TTE Apical 4 Chamber View

TEE dTG View

OTHER

Patients will receive TEE deep transgastric echo examinations after induction and after cardiopulmonary bypass induction (paced at 80, 100, and 120 bpm)

Other: TEE dTG View

TEE ME 4C View

OTHER

Patients will receive TEE midesophageal 4chamber echo examinations after induction and after cardiopulmonary bypass induction (paced at 80, 100, and 120 bpm)

Other: TEE ME 4C View

Interventions

TTE Apical 4 Chamber View OTHER

We will measure a number of echocardiography parameters by TTE (apical 4 Chamber View) prior to and after induction

TTE Apical 4 Chamber View

TEE dTG View OTHER

We will measure a number of echocardiography parameters by TEE (dTG View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)

TEE dTG View

TEE ME 4C View OTHER

We will measure a number of echocardiography parameters by TEE (ME 4C View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)

TEE ME 4C View

Eligibility Criteria

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

You may qualify if:

• ≥18 years
• undergoing cardiac surgery, and
• routinely receiving TEE for the surgical procedure, independent of the study.

You may not qualify if:

• atrial flutter or fibrillation
• severe mitral calcification
• cancelled surgery
• unwilling or unable to provide consent

Sponsors & Collaborators

• Patrick F Wouters, MD PhD: lead

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanderse, 9000, Belgium

Location

Related Publications (1)

• Mauermann E, Bouchez S, Bove T, Vandenheuvel M, Wouters P. Assessing Left Ventricular Early Diastolic Velocities With Tissue Doppler and Speckle Tracking by Transesophageal and Transthoracic Echocardiography. Anesth Analg. 2021 May 1;132(5):1400-1409. doi: 10.1213/ANE.0000000000005469.

  PMID: 33857980 DERIVED

Study Officials

• Patrick F Wouters, MD, PhD

  University Hospital, Ghent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Echo exams will be stored for later analysis by blinded assessors.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology

Model Details: Patients will receive a series of perioperative echocardiographical measurements by TTE as well as TEE prior to induction, postinduction, and post cardiopulmonary bypass

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 24, 2017
• Study Start: February 14, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: December 7, 2022

Record last verified: 2018-01

Locations

BE (1)