NCT03649854

Brief Summary

The aim of this study is to measure TAPSE in TEE using two deep transgastric views. This is a prospective comparative diagnostic study where 21 CABG patients who are enrolled for the study will be studied during the intraoperative period. The choice of general anaesthesia, hemodynamic management will be at the discretion of the anaesthesiologist in charge of the patient. The monitoring technique is standard as per any cardiac surgery with cardiopulmonary bypass. After induction of anaesthesia, TEE probe will be inserted by the PI or the Co-Investigator and the required TEE standard views and deep TG view of the right heart at zero degree and Deep TG view at 100-150 degrees will be acquired TAPSE will be measured in both the views using Mmode. The measurement will be done as follows: After acquiring the deep TG views the M mode cursor is aligned with the longitudinal motion the lateral tricuspid annulus. Once the Mmode picks up a good signal, 3 cycles are chosen and measured using calipers, and an average reading is taken. TAPSE will be used to evaluate the right heart function during the intraoperative period so that the patients with deteriorating right heart function can be identified and treatment started early. The potential benefits include the simplicity and reproducibility of the technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 15, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 23, 2018

Last Update Submit

August 25, 2018

Conditions

Keywords

TAPSERight heart function

Outcome Measures

Primary Outcomes (1)

  • New method for assessing right heart function

    TAPSE mesurement using M mode in the deep transgastric right heart view at zero degrees

    During systole intraoperatively

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for coronary artery bypass surgery at National university hospital are included in the study

You may qualify if:

  • Ejection fraction greater than 40% No other valvular involvement other than mild mitral regurgitation

You may not qualify if:

  • Hemodynamically unstable patients
  • Intubated and sedated patients
  • Emergency patients from cath lab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National university Hospital

Singapore, 119074, Singapore

Location

Study Officials

  • Lalitha Manickam

    NUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 28, 2018

Study Start

August 15, 2014

Primary Completion

March 23, 2015

Study Completion

August 14, 2015

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations