Clinical Trials

The study aims are to develop a consent-based IRB proposal that will enroll newborns who have imperforate anus.  The proposal will include permission for chart review and database information storage, to develop a database that will include MRN, imperforate anus phenotype, information on other congenital malformations, syndromic diagnosis if available, demographic information, and to develop a biobank of DNA and white blood cell samples from infants with imperforate anus. If patients are undergoing a skin biopsy for a medically indicated reason, cells will be requested.

Imperforate Anus, also known as anal atresia, is a rare birth defect.  Unable to pass stool through the gastrointestinal tract, this condition can result in death of the newborn and emergency surgery is required once discovered.  More than two thirds of affected infants have other birth defects that include other parts of the gastrointestinal tract, airway, heart, skeleton, kidneys, eyes, or ears. The exact prevalence of imperforate anus in the newborn population is unknown. 

The purpose of this study is to understand how concussion affects real-world driving behaviors and recovery over the first 21 days after injury.

The purpose of this study is that subtypes of delirium exist that remain undescribed, and which could provide a foundation for subsequent delirium prevention or treatment trials that target the underlying pathophysiology manifesting as incident or prevalent delirium.

The purpose of this study is to evaluate whether in situ simulation (ISS) adversely effects patient safety by evaluating quantitative surrogate markers including patient wait times, irregular departure rates, and reported patient safety events.  We will also evaluate ED staff/patient perceptions of the impact of ISS on workflow and experience.  Our findings may improve ISS design or refine existing best-practices.

During in situ simulation (ISS), participants manage simulated patients within their typical clinical environments and multidisciplinary teams.  This approach improves realism and engagement, enhances learning, and makes the simulations more effective.  While ISS is known to improve patient safety through the detection of latent safety threats (LSTs) – previously unrecognized systems-based issues, the potential to disrupt or negative impact patient care actively occurring alongside the simulation is an underexplored area of risk.

The purpose of this study is to develop an evidenced-based guideline for pediatric opioid prescribing guideline from the emergency department for long bone fractures to more closely tailor pain management to abuse potential. 

Intravascular catheterization is a common procedure in critically ill patients to enable measurement of hemodynamic variables, delivery of medications and nutritional support. Ultrasound-guided central venous catherization (CVC) placement has been shown to significantly reduce the number of procedural complications in comparison to the traditional landmark technique. The standard ultrasound-scanning includes two different approaches, an out-of-plane and in-plane approach. Using the out-of-plane approach could affect visualization of the needle tip during CVC placement. Complications such as posterior wall puncturing of the target vein or artery and pneumothorax can occur. When using the in-plane approach, the entire needle including the tip may be visualized, but it is technically more difficult to align the ultrasound transducer perfectly with the target vessel as well as the needle during cannulation. A novel 4D needle position technology utilizing magnetic field induction is able to detect the needle position and trajectory in both in- and out-of-plane approaches. This could potentially invaluable, especially for novice proceduralists and lead to improve procedural success and further decrease in complication rates. We hypothesize that 4D needle position ultrasound technology will lead to a significant increase in the first attempt success rate in simulated central venous catheter placement using a low-fidelity simulator . The study will be conducted in the multidisciplinary Simulation-Center, Mayo Clinic, Rochester. We will record participants’ characteristics (including demographics (gender, age), prior experience with CVC placement, prior experience with use of ultrasound, prior experience in video gaming, and assessment of spatial ability using the 24 item - Mental Rotation Test by Peters (MRT) (Peters)). Participants will be given a short tutorial to explain the procedure. CVC placement will use the low-fidelity simulator (Gen II Ultrasound Central Line Training Model, CAE Healthcare). All placements will be video recorded.

Almost one-half million people suffer venous thromboembolism annually in the United States, and one-third die from this disease. Massive bleeding from injury accounts for half of early deaths after trauma. This study aims to prevent the deaths and suffering associated with venous thromboembolism and bleeding by identifying the individual person at high risk of these complications in order to take preventive measures.

The main purpose of the database is to create and maintain an analysis-ready limited data set from multiple healthcare centers, including continuously updated data from electronic medical records and a linked prospective dataset which was previously collected through an NYULH IRB-approved multi-site research study (i24-00287 - GEARSS).