31 Clinical Trials for Various Conditions
Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration, as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association, standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase, but the patient is still exposed to the risk of atelectasis formation. This study aims to investigate the hypothesis of whether the utilization of reduced inspiratory oxygen concentration before extubation (70% or 40% compared to 100%) reduces atelectasis formation. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia. Of note, both concentrations are still higher than when breathing room air in, which has of 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO₂), heart rate, and blood pressure are recorded, and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated time points during the procedure. Anesthesia care providers are asked to document procedural, patient, and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (\<90% SpO₂), incidence of re-intubation or non-invasive ventilation, and the Post-anesthesia Care Unit (PACU) length of stay.
Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis. We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.
To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.
To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography
This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing bronchoscopy under general anesthesia. Ventilatory strategy to prevent atelectasis (VESPA) may work better than standard of care mechanical ventilation to reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia.
This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.
This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device (see appendix A for device details) combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance. This study addresses postoperative pulmonary atelectasis that results from diaphragm dysfunction and pain following upper abdominal surgery. This issue is a major cause of morbidity in these patients (Ford et al 1983). Incentive spirometry is used in this setting, but there is conflicting data regarding its effectiveness (Rupp et al 2013). Study 3 will focus on the questions regarding the influence of education and a novel use of a gaming device on prevention of atelectasis. Study 3 will include 3 subgroups of subjects. The first subject group will be enrolled in a nonintrusive observation only studies. Group 1 will explore the effect of technology via a tablet device on standard spirometry usage. Group 2 will look at the combined effect of technology via the tablet device and intensive education on compliance and reduction of post-surgical atelectasis. Finally, Group 3 will explore the effect of gaming technology with intensive educational reinforcement on compliance and reduction of post-surgical atelectasis.
The purpose of this study is to better understand how air is spread throughout study participants' lungs after abdominal surgery by comparing two lung inflation treatments: 1. Incentive Spirometry (I.S.) lung expansion therapy 2. EzPAP® lung expansion therapy. Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths after surgery helps lungs to stay inflated. At the University of Virginia, it is at the physician's discretion as to which treatment will be used to help with deep breathing lung inflation therapy after surgery. The investigators would like to know which of the lung inflation therapies is better at helping inflate participants' lungs. The investigators will be using a device called Electrical Impedance Tomography (EIT) to measure how effectively air spreads in participants' lungs. This device is not currently approved by the Food and Drug Administration (FDA) for the purpose used in this study, and therefore, it is considered investigational. Investigators are inviting eligible participants to consider participating in this study because doctors order Incentive Spirometry as a standard of care following upper abdominal surgery. Information gained from monitoring how air is spread throughout participants' lungs will help investigators to determine if there is a clinical difference and benefit when comparing Incentive Spirometry and EzPAP lung expansion therapies.
To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.
The purpose of this study is to determine whether breathing high levels of oxygen during surgery affects oxygen levels after surgery. The second purpose of this study is to determine whether giving positive end expiratory pressure PEEP and high oxygen together affects patients oxygen levels after surgery.
The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.
This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients. The two specific aims of this study are to conduct an initial pilot study with the following goals: 1. To obtain information on feasibility and utilization of the program 2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure
Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.
The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.
The primary purpose of this study is to determine if there is a significant difference in regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects. Electrical impedance tomography (EIT) will be used to measure regional distribution of ventilation during resting tidal ventilation and during lung expansion therapy.
Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies. The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.
To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath.
Flexible bronchoscopes are typically reusable and therefore need high level disinfection to prevent inadvertent spread of microbial pathogens from patient to patient. The process of disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may not be readily available for another patient. One solution to this problem was to use a single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of the bronchoscope.(Colt, Beamis, Harrell, \& Mathur, 2000). Another way to eliminate potential hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen \& Fredensborg, 2013; Pujol, López, \& Valero, 2010; Tvede, Kristensen, \& Nyhus-Andreasen, 2012). Further advancement in the imaging and handling of this disposable flexible bronchoscope now allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients with pulmonary compromise. (FDA approval: 05-11-2013 date) The aim of the study is to compare image clarity, suction capacity, and handling performance of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the investigators intend to perform a cost analysis.
The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
The purpose of the protocol is to assess how incentive spirometer data gathered via a smartphone platform can be utilized to improve participant adherence to prescribed incentive spirometer exercises in the post-operative period. Half of the participants will receive a standard of care incentive spirometer with a passive tracking device while the other half of the participants will receive a smartphone connected device and smartphone with an application that will encourage their use.
The purpose of this study is to measure the density of a temperature-sensitive protein, named TRPV1, in the airway mucosa tissue of both non-asthmatic and moderate to severe persistent asthmatic patients. This study may generate information for developing new therapeutic strategy.
Aim of this study is to better understand pathophysiology of the alteration of respiratory mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to test this hypothesis with a physiological, interventional study conducted on volunteers by using Electrical Impedance Tomography in a group of patients and magnetic resonance imaging (MRI) in another group.
The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.
This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.
This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).