Pittsburgh, Pennsylvania 15213

  • Heart Diseases

Purpose:

Speckle tracking imaging measuring software will be used for offline analysis of transesophageal echocardiogram (TEE) -acquired images of the left ventricle(LV) in four chambers(4C), two chambers (2C) and long axis (LAX) views to calculate global longitudinal strain (GLS) of LV for comparisons between sevoflurane and isoflurane at the same minimum alveolar concentration ( MAC) levels.


Study summary:

The primary research activity will be: baseline transthoracic echocardiogram (TTE) views taken upon the patient entering the operating room by one of the cardiothoracic anesthesiology fellows or attendings, TEE views taken by the echocardiography fellow or attending in the mid-esophageal 4C, 2C and LAX views once the patient has reached sevoflurane end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5. Following this, sevoflurane will be changed to isoflurane and wait till complete washout of sevoflurane (i.e. end-tidal sevoflurane concentration reaches zero). Isoflurane concentration will be adjusted according to bispectral index and hemodynamics to maintain anesthesia during this period. Once complete sevoflurane wash-out has been achieved, isoflurane concentration will be adjusted and repeat images taken at the 0.5, 1.0, and 1.5 MAC values. Investigators will establish stability at each MAC level (0.5, 1.0 and 1.5) for 5 minutes before obtaining TEE images. The whole study is done during pre- cardiopulmonary bypass(CPB) period while surgeon spending time dissecting internal mammary artery or other parts of surgical dissection before heparinization. The entire study duration will be a maximum of 35-40 minutes and this will not prolong the operating time. The adjustment of the anesthetic will be performed by the cardiac anesthesiology fellow or senior resident involved in this research along with the faculty officially performing the case. All images will be acquired prior to the initiation of cardiopulmonary bypass by the echocardiography rotating resident or research resident, cardiac anesthesiology fellow or cardiac anesthesiology attending anesthesiologist (all received extensive training in TEE to obtain those required images). Following the completion of the case and the uploading of images to a central echocardiography server, one of the study personnel will perform analysis of the images in the anesthesiology offices on a computer with post-processing software to determine strain. MAC up to 1.5 is very well tolerated in cardiac surgical patients and is routinely used to achieve hemodynamic conditions during surgery. Use of vasopressor and inotrope to allow maintain depth of anesthesia with inhalation anesthesia agents is also routine in cardiac surgical patients and not in any way different from routine clinical care. Hemodynamic information (heart rate, blood pressure, central venous pressure, cardiac index or pulmonary artery pressure) will be obtained after stabilization with each MAC and will be recorded immediately or extracted from the electronic medical records.


Criteria:

Inclusion Criteria: Adult Patients (> 18 years of age) undergoing cardiovascular surgery at University of Pittsburgh Medical Center (UPMC) Presbyterian hospital. Exclusion Criteria: Inability to comprehend and understand the study, Pregnancy Malignant hyperthermia Acute cardiogenic shock and ongoing chest pain Permanent pacemaker with pacemaker dependency Abnormal cardiac rhythms ( e.g. atrial fibrillation) Contraindications to TEE examination such as recent esophageal surgery, esophageal cancer/stricture The use of anesthesia maintenance with intravenous anesthesia drugs such as propofol infusions


Study is Available At:


Original ID:

PRO17080624


NCT ID:

NCT03569085


Secondary ID:


Study Acronym:


Brief Title:

Inhaled Anesthetics and Myocardial Strain


Official Title:

Effect of Inhalational Anesthetics on Myocardial Deformation Indices - A Dose-Response Cross-over Study


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kathirvel Subramaniam, MD, MSc
Principal Investigator
University of Pittsburgh
Primary Contact:Ezeldeen Abuelkasem, MD, MSc
4122099819
abuelkaseme@upmc.edu

Study Dates

Start Date:June 27, 2018
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:December 2021
Primary Completion Type:Anticipated
Verification Date:November 2020
Last Changed Date:November 15, 2020
First Received Date:June 1, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Global longitudinal strain of myocardium, unitless (Dose dependent effect of isoflurane)
Time Frame:Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass
Safety Issues:False
Description:Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate glo
Outcome Type:Secondary Outcome
Measure:Global longitudinal strain of myocardium, unitless (Dose dependent effect of sevoflurane)
Time Frame:Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass
Safety Issues:False
Description:Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate glo
Outcome Type:Primary Outcome
Measure:Global longitudinal strain of myocardium, unitless (Comparison between two inhalational anesthetics, isoflurane and sevoflurane)
Time Frame:Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass
Safety Issues:False
Description:Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate glo

Study Interventions

Intervention Type:Drug
Name:Isoflurane
Description:The patient will receive isoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.
Arm Name:Sevoflurane then isoflurane
Intervention Type:Drug
Name:Sevoflurane
Description:The patient will receive Sevoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.
Arm Name:Sevoflurane then isoflurane

Study Arms

Study Arm Type:Experimental
Arm Name:Sevoflurane then isoflurane

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kathirvel Subramaniam

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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