Clinical Research

Manuel Fontes 1

Manuel Fontes, MD

During my 23 years as a researcher and clinician, I have gained expertise and knowledge in the field of cardiovascular medicine as it applies to anesthesiology and critical care. My experience in clinical research also includes leadership responsibilities as Director of Clinical Research at Weill Medical College of Cornell, at Duke University Medical Center, and more recently, at Yale University School of Medicine. A few examples of our research include investigating microthrombotic events and factors that exacerbate perioperative ischemic complication in major vascular surgery, in open-heart surgery, in the setting of ventricular assist device implantation, and in obstetric and pediatric surgery. We are also involved with several multicenter trials in cardiac surgery including: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery with Cardiopulmonary Bypass (Grifols Therapeutics, Inc.). Lastly, we are both committed and excited about the future of research in the Department of Anesthesiology and are invested in our mission and vision, which is guided by a highly experience group physician-scientist known as the Senior Research Board (Drs. Roberta Hines, Paul Barash, Mathew Burg, Manuel Fontes, Paul Heerdt, Laura Niklason, Albert Perrino, Kirk Shelley). 

Research Newsletter 2018

Research_Newsletter_2018
Ayman Alian, MD

Ayman Alian, MD

Dr. Alian is an Associate Professor of Anesthesiology, board certified anesthesiologist, clinical researcher and interim Division Chief for Obstetrics & Gynecologic Anesthesiology. Dr. Alian is a nationally recognized educator and has received several Faculty Awards of Excellence in education and mentorship. His clinical research is dedicated to the investigation of cardiopulmonary and autonomic physiology through the use of non-invasive monitors. Ongoing studies in Dr. Alian’s laboratory focuses on pulse oximetry and cerebral oximetry waveforms as sensitive biomarkers of central hypovolemia during anesthesia-surgery.


Dr. Alian is the principal investigator on several IRB approved clinical research studies listed below:


• “Tissue saturation monitoring in pregnant women”

• “Hypovolemia and LBNP waveform analysis”

• “Expiron and detection of respiratory suppression” (Sponsored by Expiron)

• “Plethysmographic and Peripheral venous waveform analysis in adult surgical patients”

• “Plethysmographic and peripheral venous waveform analysis in pediatric surgical patients”

Shamsuddin Akhtar, MD

Shamsuddin Akhtar, MD

Dr. Akhtar is an Associate Professor of Anesthesiology and Pharmacology and a nationally recognized educator and leader of clinical anesthesiology. He is board certified in both Anesthesiology and Critical Care Medicine. Dr. Akhtar has conducted groundbreaking studies of surgical patients demonstrating that elderly patients are consistently administered higher than recommended doses of intravenous induction anesthetics and the incidence of hypotension provoked by the anesthetic induction dose was significantly higher in the elderly patients, which resulted in higher use of rescue pressor therapy to maintain adequate blood pressure. Currently, Dr. Akhtar is part of a clinical study which use the Multicenter Perioperative Outcomes Group (MPOG) database to determine the association of anesthetic induction dose - with clinically meaningful hypotension that occurs prior to the initiation of the surgical procedures among patients age≥65, and separately among those age ≥ 80.

Dr. Akhtar is the principal investigator of several clinical research studies, including a principal site investigator for a multi-institutional study titled ‘A Randomized Controlled Trial of Regional versus General Anesthesia to Promote Independence after Hip Fracture (REGAIN Trial)’ funded by PCORI. He has also completed a textbook entitled “Principles of Geriatric Critical Care” to be published by Cambridge University.

Rob Schonberger

Rob Schonberger

Dr. Schonberger is an Associate Professor of Anesthesiology and Informatics and serves as the Associate Director for Clinical Research in the Department of Anesthesiology. His research investigates ways of integrating perioperative encounters into long-term cardiovascular risk-factor reduction. His group recently demonstrated the strong association between preoperative blood pressure elevation and poorly controlled home blood pressures among surgical patients (Table Below ) J Am Soc Hypertens. 2018 Apr;12(4):303-310. doi: 10.1016/j.jash.2018.01.012. Epub 2018 Feb 6.

PMID: 29486981).



Dr. Schonberger is also the site PI for Yale’s participation in the Multicenter Perioperative Outcomes Group (MPOG), an international consortium focused on research and quality improvement in the perioperative space and is involved in several database oriented research projects with both industry and academic collaborators. 

Clinically, he serves as a member of the Cardiac Anesthesiology section. Dr. Schonberger is also a mentor to trainees and junior faculty who are interested in conducting clinical research and is the Departmental head of the Clinical Scientist Track within the Anesthesiology residency program. A partial list of prior mentees and their accomplishments is listed below: 

Track record of mentorship including citations: 

T32: 

Dr. Adambeke Nwozuzu: 

Nwozuzu A, Fontes ML, Schonberger RB. Mobile Extracorporeal Membrane Oxygenation (ECMO) Teams: The North American vs. European Experience; Journal of Cardiothoracic and Vascular Anesthesia. 2016 Dec;30(6):1441-1448. PMID: 27686513 

CST: 

Dr. Julia Rosenbloom: Dr. Rosenbloom also successfully applied to the Committee on Professional Diversity, won the Anesthesia History Association best manuscript award, and subsequently published the following manuscripts: 

Rosenbloom JM, Schonberger RB, Toward an understanding of the equality of pain: Crawford Long and the development of anesthesia in antebellum Georgia. Journal of Anesthesia History 2015 Jan; 1:14-7. PMID 25748368 

Rosenbloom JM, Schonberger RB, The Outlook of Physician Histories: J. Marion Sims and “The Discovery of Anaesthesia.” BMJ: Medical Humanities 2015 Dec;41(2):102-6. PMID: 26048369 

Fellows: 

Dr.Luiz Maracaja-Neto: 

Maracaja Neto L, Modak R, Schonberger RB. Orthogonal Views of Coronary Vessels: a Method for Imaging the Delivery of Blood Cardioplegia using TEE; Anesthesia & Analgesia 2017 Apr;124(4):1087-90. 

YSM: 

Dr. Kyan Safavi: 

Safavi K, Dai F, Gilbertsen T, Schonberger RB, Variation in surgical quality measure adherence within hospital referral regions: Do publicly reported surgical quality measures distinguish among hospitals that patients are likely to compare?, Health Services Research 2014 Aug;49:1108-20. PMID: 24611578 

Dr. Charles Odonkor: 

Odonkor CA, Schonberger RB, Dai F, Shelley KH, Silverman DG, Barash PG, New utility for an old tool: can a simple gait speed test predict ambulatory surgical discharge outcomes?, American Journal of Physical Medicine and Rehabilitation 2013; 92(10):849-63. PMID 24051992 

Eric Chen (YSM 4): 

Chen EY, Sukumar N, Dai F, Akhtar S, Schonberger RB. A Pilot Analysis of the Association Between Types of Monitored Anesthesia Care Drugs and Outcomes in Transfemoral Aortic Valve Replacement Performed Without General Anesthesia.J Cardiothorac Vasc Anesth. 2017 Jul 12. pii: S1053-0770(17)30654-7. doi: 10.1053/j.jvca.2017.07.009. [Epub ahead of print] PMID: 29277298 

RSB
(Table at Right (JASH, in press)).
kirk s

Kirk Shelley

Our lab is dedicated to the investigation of cardiopulmonary and autonomic physiology through the use of non-invasive monitors. This is accomplished through carefully documented clinical observations during surgical procedures (e.g. scoliosis, craniofacial, laparoscopic and shoulder surgery). We also perform normal volunteer studies under a wide variety conditions (e.g. lower body negative pressure, blood withdrawal & replacement, positioning & respiratory maneuvers).

In recent years our focus has been on the pulse oximeter and peripheral venous pressure waveforms. The collected waveforms are then analyzed using digital signal processing. The primary goal is a better understanding of the underlying physiology. The secondary goal is the use of this understanding to develop new methods of patient monitoring. This work so far has generated over 100 research abstracts, 40 peer reviewed papers, and numerous patents.

Most recent efforts have been focused on integrating our research findings into the larger field of functional hemodynamics which combined with early goal directed therapy has been shown to improve patient outcomes. Functional hemodynamics is an exciting approach to the care of patients based upon the principle that the individual patient needs to be optimized to their specific cardiac, pulmonary, and vascular physiology. A key advance has been the recognition that the interactions, between the respiratory, cardiac and autonomic systems, lead to important clues regarding the status of each.

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Matthew M Burg

Matthew Burg

Dr. Burg has for over 25 years conducted a federally funded program of research on the pathways by which stress and emotional factors contribute to risk for hypertension and cardiovascular disease, and contribute to prognosis after acute cardiac events. In the context of clinical trials, he has also investigated how best to address this risk, using new models of care delivery. His current interests extend to post-traumatic stress in Veterans returning from conflicts in Iraq and Afghanistan, and early surveillance for cardiovascular disease risk associated with this disorder.

Lz

Lingzhong Meng

Dr. Meng’s clinical research has been focusing on the following aspects.

Improving patient outcome via optimization of tissue perfusion and oxygenation. Tissue ischemia & hypoxia is one of the root causes of certain perioperative morbidities. Timely detection and correction of tissue ischemia & hypoxia contribute to an improved outcome. The first step of this query is the capacity to reliably monitor tissue perfusion and oxygenation. The advent of tissue oximetry based on near-infrared spectroscopy (NIRS) enables the clinician to monitor tissue oxygenation continuously and non-invasively at the patient’s bedside. Research has been done to understand how the perioperative factors affect cerebral oxygenation monitored using NIRS. Investigation has also been done to understand how intraoperative tissue oxygenation of different tissue beds, cerebral vs. muscular, is associated with postoperative outcome. Yet, the fundamental step of this query is to test if tissue oxygenation – guided care improves the patient outcome in high-risk scenarios. Even though outcome research has been done previously, various methodological limitations exist. The future research should address the definition of an individual patient’s baseline value, the threshold for intervention, the differential diagnosis of tissue hypoxia, and the patient populations that benefit from tissue oxygenation monitoring.

Improving patient outcome via choosing the appropriate anesthetic technique. The aspects of anesthetic technique include, but not limited to, monitored anesthesia care vs. general anesthesia, laryngeal mask airway vs. endotracheal tube, inhalational vs. intravenous agent, the strategies of hemodynamic management, and the mode and setting of mechanical ventilation. The available evidence has suggested an association between anesthetic technique and patient outcome. However, due to the multiplicity of the aspects of anesthetic technique and the complexity of randomized controlled trial in clinical setting, much work is needed to better understand the effect of different aspects of anesthetic technique on patient outcome.

Jodi Sherman

Jodi Sherman

The environmental impact of perioperative services is among the largest in all of medicine. Inhaled anesthetics account for 5% of hospital emissions, and 33% of hospital solid waste is generated in the ORs. Anesthesiologists have a unique opportunity and responsibility to improve the pollution profile of our specialty, however little is presently known where to target our efforts. The central goal of Dr. Jodi Sherman research in the Yale University Department of Anesthesiology is to quantify the environmental and public health effects of common drugs and devices for entire anesthetic pathways, so these results may aid in targeted waste reduction and pollution prevention strategies where choices exist, as they often do in clinical practice. Dr. Sherman collaborates with Dr. Julie Zimmerman, Ph.D. and other environmental engineers from the Yale School of Forestry and Environmental Sciences, applying Life Cycle Assessment (LCA) scientific modeling to questions in anesthetic practice, quantifying energy, greenhouse gas emissions, human health impacts, and economic densities of therapeutic drugs, OR devices, and perioperative behaviors to help guide clinical decision making toward more ecologically sustainable practices. Dr. Sherman also serves on the Environmental Task Force of the American Society of Anesthesiologists.

The Research Advisory Council provides guidance for research and scholarly activities of faculty, trainees and students.  Members of the RAC are: 

Roberta Hines, MD 

Helene Benveniste, MD, PhD

Matthew Burg, PhD

Manuel Fontes, MD

Paul Heerdt, MD, PhD

Laura Niklason, MD ,PhD

Robert Schonberger, MD

Shaun Gruenbaum, MD, PhD


Internal IRB Committee

Internal IRB Committee meets weekly to review all open studies in the department and provide guidance, regulatory support, assistance with study implementation.

Manuel Fontes, MD

Paul Heerdt, MD

Helene Benveniste, MD

Robert Schonberger, MD

Aymen Alian, MD

Matthew Burg, PhD

LZ Meng, MD

Feng Dai, PhD, Statistician

Karen Stavris, RN

Kim Kunze, RN

Anesthesiology Research Support Staff

The research support staff facilitates collaboration across many research disciplines to operationalize both investigator initiated and industry sponsored studies. We provide assistance with study design; IRB submissions and ongoing regulatory support; data management and general study oversight.

Karen Stavris, MSN, RN, CCRC

Kimberly Kunze, MSN , RN, CCRP

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