32 Clinical Trials for Various Conditions
The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are: Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures? Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies? Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills. Participants will: Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.
The goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation. There are 3 Aims for this study that the investigator will test, but the Aim that is the interventional portion of this study is only reported here in Aim 2 - Establish the validity and effectiveness of high-fidelity immersive virtual simulation-based training in improving operating room quality and safety.
This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.
External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.
According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide. STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.
The purpose of this study is to assess the effect of a non-operating room anesthesia (NORA) safety video on clinician anxiety and perceived self-efficacy.
The purpose of this study is to test the safety and efficacy of a new isolation device to contain aerosol during aerosol-generating procedures in the operating room.
Determine whether operating room air filtration and sterilization with the ActivePure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.
Testing ULTRAPREP (consists of a clear bag sealed on one end with the other end enclosing the patients extremity) for safety and efficacy to perform skin antisepsis outside the operating room.
The purpose of this research study is to test the safety, tolerability, and effectiveness of watching streamed videos through virtual reality (VR) goggles during surgery. The results of this study will be used to evaluate whether video-streaming services on VR goggles are worthwhile additions to standard anesthesia care during total knee surgery.
The purpose of this trial is to compare operating room time between conventional treatment techniques \[without Virtual surgical Planning (VSP)\] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).
This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.
Patients becoming infected during hospitalization occurs frequently and causes harm. It is important for healthcare facilities to take action to prevent these infections and their spread between patients. Despite the presumption of a "sterile" environment, one place where spread of infection is known to happen is in the operating room. This occurs as a result of frequent interaction among healthcare providers, the patient and the environment of the room. Hand washing is an important component of preventing the spread of infections. Scientific evidence has shown that making it easier for people to wash their hands can have two important impacts: (1) reduction of environmental bacterial contamination and (2) reduction in spread of bacterial pathogens. OR PathTrac is new technology that allows tracking of bacterial spread. While data exists about bacterial contamination and transmission in the adult operating room, there is very minimal data about this in the pediatric operating room. Primary aim: To use OR PathTrac to evaluate the effect of a personal hand washing device in reducing operating room exposure to bacterial pathogens in pediatric patients. We hypothesize that this hand washing system will decrease exposure to pathologic bacteria in the pediatric operating room. Secondary aim: To gain knowledge about baseline bacterial contamination and transmission in pediatric operating rooms. We will answer this question by comparing bacterial cultures taken from operating rooms whose personnel are trained to use the hand washing device to operating rooms who are not trained to use the device.
Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.
This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.
This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.
The objective of this study is to look at critical events in the pediatric operating room in a retrospective and now prospective fashion to determine if there are any trends such as age, presence of URI, type of surgery, type of airway, level of hands on provider, or other predictive markers associated these events so that we may gain some insight into perhaps reducing the incidence of these events or simply be more attune to the increased risks in certain situations.
Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated surgical suite environmental system, called SignatureSuite™, that controls the level of lighting, images on OR monitors, and ambient background audio via preset, computerized automation for use before and after anesthesia. This study aims to determine if this new type of operating room environment decreases anxiety, as measured by patient responses on anxiety visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use. The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland Clinic Marymount Hospital versus the standard operating room environment. Randomization will occur at the surgeon level. There will be a maximum 100 patients divided equally between the experimental and control arms of the study.
The goal of the study is to identify factors that enhance productivity and increase value delivered by hospitals drawing on concepts used in industry for quality and productivity in production and operations management literature. The investigators intend to look at surgeon experience, patient characteristics and pre-admission testing on operating room productivity.
Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions of others within the team can have direct, immediate, and preventive effect on adverse outcomes. However, little is known about the hurdles and enablers of this behavior in healthcare, especially within the operating room setting. Objective 1. Determine if an educational workshop would improve speaking-up behaviors of practicing anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the self-reported hurdles and enablers for speaking-up in those situations encountered. Design Randomized controlled experiment of an educational workshop intervention on communication behaviors in a simulated case. Qualitative analysis of debriefing conversations following the simulated case. Setting Established academic simulation center Participants Seventy-one practicing anesthesiologists from four academic medical centers and one community hospital Intervention Fifty minute educational workshop on speaking-up that included rationale, conversational techniques, a rubric for speaking-up, and role-play.
Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are accomplished laparoscopically in the investigators current surgical practice to allow women a quicker recovery than a traditional large incision. Disposable laparoscopic devices have been developed to assist in the completion of hysterectomies. These disposable energy sources are only used once, but offer an improved safety and energy profile in that they reliably control bleeding with little damage to surrounding tissue and potentially save time. Reusable energy instruments can be sterilized and reused for multiple cases. Operating room time is expensive. The investigators calculate that if 6.7 minutes of time can be saved using the disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz Laparoscopic Shears, the time savings could justify the cost of the device.
This study compares two different methodologies of scheduling cases in the operating room.
All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI) between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will look at the flow of staff people in and out of the operating room during surgeries and the effect that the number of people may have on the rate of infections in the surgical sites.
In this study, subjects meeting criteria will be enrolled and randomized to one of two different suctioning schemes, either continuous or intermittent. Accumulated secretions will be collected above the cuff on the breathing tube by one of the two methods depending on which group the subject is randomized into. Secretions will continue to be collected at predetermined periods of time for the duration of surgery in order to characterize the pH and volume as well as the micro-organism content.
The purpose of this study is to establish viable cell culture system techniques for a variety of healthy and diseased tissues for use in future in vitro and in vivo research studies in tissue engineering.
The pollution of the operating room environment by anesthetic agents had been questioned, studied and documented in the past. These investigations demonstrated the existence of teratogenic effects in animals and the possibility of a decrease in mental performance, reduced fertility, fetal loss, spontaneous abortion and addictive potential in humans with chronic exposure to trace amounts of anesthetic agents. These findings led to the establishment of exposure limits and industry standards by consumer protection agencies, such as National Institute for Occupational Safety and Health (NIOSH). However, these standards applied to inhalation anesthetic agents that were excreted from the lungs of patients during expiration. These concerns about operating room pollution weaned away with the introduction of intravenous anesthetic agents, such as propofol, because it was believed propofol was excreted by systems other than the lungs. Recent research points to the contrary and demonstrates the excretion of propofol vapor in the expired gases of patients. Furthermore, animal experiments in our laboratory establish the existence of a biological mechanism responsible for addiction in animals exposed to trace amounts of propofol. We propose to study the exposure levels of anesthesia care providers in the operating room, during propofol use, under standardized conditions. Our findings will help to establish preventive measures for propofol addiction in anesthesia care providers.
The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.
Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.
With approval of the IRB at the Cleveland Clinic and written informed consent, the investigators propose to study up to 20 healthy volunteers in the protocol below as this will allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient power to detect clinically-meaningful differences between laminar air flow treatments. The study has been designed to find out whether heat loss increases significantly in laminar air flow operating rooms. Furthermore the investigators will find out whether active warming minimizes this heat loss. Increased heat loss increases the amount of perioperative hypothermia. It has been shown that perioperative hypothermia is associated with severe complications such as an increased incidence of surgical wound infections. On the other hand laminar air flow is explicitly used to decrease air-borne infections. Our study results will help to optimize thermal management of orthopedic patients.