Echocardiography, Transesophageal Clinical Trial
— TEEOfficial title:
Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function
Verified date | June 2019 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and
diagnosis in the perioperative setting for critically ill patients and patients undergoing
cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography
(TTE) data and have not validated by transesophageal means. The aim of this study is to
validate TEE assessment of right ventricular function by comparing them to simultaneously
measured TTE measurements.
Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the
investigators will attempt to define a range of normal values of RV free wall strain as
compared to the other measures of RV function.
Status | Completed |
Enrollment | 126 |
Est. completion date | October 10, 2018 |
Est. primary completion date | October 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients undergoing elective cardiac surgery requiring TEE Exclusion Criteria: - Patient who do not wish to consent - Patients with contraindications to TEE - Urgent or emergent cardiac surgery - Patients with preexisting open chest - Patients with intrathoracic hardware (VAD, thoracostomy tube, etc) - Non-English speaking subjects - Cognitively impaired adults - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right ventricular index of myocardial performance (RIMP) | Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE. | Immediately following the induction of anesthesia and TEE probe placement | |
Primary | Tricuspid annular plane systolic excursion (TAPSE) | Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE. | Immediately following the induction of anesthesia and TEE probe placement | |
Primary | Right ventricular fractional area change (FAC) | Right ventricular fractional area change (FAC) will be measured using both TTE and TEE. | Immediately following the induction of anesthesia and TEE probe placement | |
Primary | RV annular systolic velocity (S`) | RV annular systolic velocity (S`) will be measured using both TTE and TEE. | Immediately following the induction of anesthesia and TEE probe placement | |
Primary | RV free wall longitudinal strain | RV free wall longitudinal strain will be measured using both TTE and TEE. | Immediately following the induction of anesthesia and TEE probe placement | |
Secondary | Ease of obtaining appropriate TEE measures of right ventricular function | Ease of acquisition will be assessed by the echocardiographers | Within 15 minutes following anesthesia induction | |
Secondary | Define values for normal right ventricular free wall strain | The data collected will be used to define normal values for right ventricular free wall strain | Through study completion, an estimate of 1 year |
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