Treatment Trials

24 Clinical Trials for Various Conditions

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COMPLETED
Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
Description

Dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (CS). Although alterations in respiratory-swallow coordination is a known underlying pathophysiologic mechanism of dysphagia in multiple patient populations, no group has examined respiratory-swallow physiology in CS patients. The proposed study will examine respiratory-swallow physiology in CS patients and determine its association with unsafe swallowing and inferior health-related outcomes.

COMPLETED
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
Description

The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.

RECRUITING
Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
Description

Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy.

RECRUITING
The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications
Description

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

COMPLETED
Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
Description

The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

COMPLETED
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Description

The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

COMPLETED
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Description

Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.

COMPLETED
BRS and Outcomes in Cardiothoracic Surgery
Description

The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).

COMPLETED
Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Description

A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone marrow in patients undergoing cardiothoracic surgery.

COMPLETED
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
Description

The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both medications. The investigators will randomize patients to receive either morphine/midazolam as needed intermittently or morphine/midazolam drips plus intermittent doses to be received as needed. Pain scores will be recorded and total medications given will be recorded.

COMPLETED
Objective Assessment of Technical Skills in Cardiothoracic Surgery
Description

The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability.

COMPLETED
Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
Description

The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

COMPLETED
Transfusion Strategies in Pediatric Cardiothoracic Surgery
Description

The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.

COMPLETED
Effects of Thymectomy During Cardiothoracic Surgery
Description

The thymus is known to be the site of T cell development in humans. Due to its location in the chest in front of the heart, incidental thymecomy is commonly performed during cardiothoracic surgery, especially in infants and children, so that surgeons may gain access to the surgical field. This practice has been considered safe because it was thought that the thymus is inactive after birth. However, recent data using newly developed techniques has demonstrated that the thymus normally is active well into adulthood. In addition, in a previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T cells) number in individuals who have undergone thymectomy in childhood but we do not know how immunity is affected. We plan to investigate if immune development or immune function later in life is affected by the loss of T cell production caused by thymectomy during cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen who have congenital heart disease and undergo surgical procedures for correction or repair and many children and adults are followed for many years after they have undergone surgical procedures. Subjects for study will be recruited from among these patients. We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood. We will determine if these subjects have had complete thymectomy in the past using CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic surgery, by visualization of thymic tissue during the procedure. In addition we will give vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from a blood sample). As part of this study, we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses (such as asthma), a history of infections and hospitalizations, and information about immunizations. We will also ask about a list of specific symptoms which will give us information about the function of the immune system.

UNKNOWN
Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
Description

Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery

UNKNOWN
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
Description

This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.

TERMINATED
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery
Description

This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.

COMPLETED
Fortified Skimmed Mother's Milk in the Management of Chylothorax
Description

The purpose of this study is to determine if the use of fortified skimmed mother's milk is a safe alternative to specialized formula in the treatment of chylothorax following cardiothoracic surgery.

TERMINATED
Natrecor in Pulmonary Hypertension
Description

The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.

COMPLETED
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Description

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Conditions
COMPLETED
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
Description

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).

COMPLETED
Quality of Life After Open Heart Surgery in Older Patients
Description

Long term follow-up of nonagenarians who have undergone open heart procedures.

RECRUITING
Etomidate Versus Propofol in CABG Surgery
Description

The objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. The primary aim of this study is to determine whether patients receiving etomidate or propofol exhibit similar requirements for vasopressor or ionotropic agents during both the intraoperative and postoperative periods. To achieve this goal, participants who are scheduled for CABG surgery will be randomly assigned to receive either etomidate or propofol as the principal hypnotic agent. The researchers will then compare the effects of these two anesthesia induction agents on various factors, including the need for hemodynamic support, hemodynamic stability, duration of mechanical ventilation, length of stay in the intensive care unit (ICU), and overall hospital length of stay. Additionally, they will assess whether there are disparities in mortality rates and readmission rates within a 6-month timeframe after the surgery. By comparing the outcomes between the two groups, the study aims to provide valuable insights into the potential differences in vasopressor or ionotropic agent requirements between etomidate and propofol. This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.

COMPLETED
Identification of Dominate Stressors in the Intensive Care Unit (ICU)
Description

Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery. The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery. Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU. The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.