42 Clinical Trials for Various Conditions
SUMMARY: This is a quantitative, non-inferiority study using healthy participants to compare tidal volumes at rest measured by both a standard RIP belt and a flow-regulated nasal oxygen delivery system FRNDS cannula. Recording of tidal breathing is essential for patients undergoing evaluation for respiratory disease and reduced exercise capacity. Conventional spirometry techniques involving pneumotachometers are currently employed worldwide in pulmonary testing laboratories to record pulmonary flow and calculate tidal volumes by allowing subjects to breath out of mouth into these devices. However, concurrent use of pneumotachometers while testing a novel nasal device is not feasible. Respiratory inductive plethysmography (RIP) has been developed and validated to evaluate tidal ventilation during quiet breathing using a band around the chest. RIP signals may be contaminated by body movements resulting in artifacts which may be a limitation. However, although a crude method when compared to spirometry, RIP remains a viable method for comparison. FRNDS is a novel cannula device that can both measure tidal volume (VT) in real time while simultaneously delivering air to the patient. The gold-standard of measuring VT clinically is spirometry; however, this test cannot be completed when patients are receiving supplemental oxygen or air. Thus far, the FRNDS cannula has been tested in vitro with a cylindrical flow model and has accurately measured simulated VTs with 80% accuracy, but has not yet been validated in Human subjects. To assess the devices robustness in a clinical scenario is essential to the development and eventually adaptation of FRNDS in clinical care. OBJECTIVES:- In this study the investigators aim to describe and validate flow-regulated nasal oxygen delivery system (FRNDS) instrumented nasal cannula as a non-inferior methodology of measuring flows at the nasal interface compared to conventional methods (e.g., RIP belts) with the added benefit of administering a dose of air to the subjects. While the FRNDS device was validated in vitro in a cylindrical model, the investigators aim to show equivalence to standard respiratory measurement methods in healthy subjects. This milestone will be essential towards the eventual translation of an adaptive cannula system that measures and adjusts air flow according to patient needs in real time. ENDPOINTS: The primary endpoint of this study is the continuous measurement of a test subjects Vt and Minute ventilation ( VE) while simultaneously delivering variable volumes of air to the patient and comparing these results with Vts and VE captured with conventional technology (RIP belts). The investigators will also be collecting inspiratory time (Ti) expiratory time (Te) continuously and a single measurement of nasal cavity openings (e.g., internal vertical and horizontal dimensions 1 cm inside the nares using calipers)
Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.
The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.
The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.
The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep.
To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19.
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.
1) Oxygen Transport in Normobaric versus Hypobaric Hypoxia. 2) The purpose of this study is to examine acute responses in arterial and muscle tissue oxygenation during incremental exercise in normobaric versus hypobaric hypoxia. 3) The participants in this study will consist of 12 recreationally active males and females between the ages of 19 and 45.Recreationally active is defined as participating in moderate to vigorous physical activity for 30 minutes at least 3 days per week.4) Subjects will complete an incremental cycle test to volitional fatigue in three conditions in a randomized counter-balanced order, normobaric normoxia (20.9% O2, 730 mmHg), normobaric hypoxia (14.3% O2, 730 mmHg) and hypobaric hypoxia (20.9% O2, 530mmHg). Two of the three trials will be conducted in an environmental chamber to simulate normobaric normoxia at 350 m (elevation of Omaha, NE) and normobaric hypoxia at 3094 m (elevation of Leadville, CO). The hypobaric hypoxia trial will be conducted in Leadville, Colorado at 3094 m. Trials will be separated by at least two days. Rating of perceived exertion, heart rate, blood oxygenation, respiration rate, muscle tissue oxygenation, and whole body gases will be analyzed during the trials. 5) There is no follow-up as a part of this study.
The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study. The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.
This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.
Purpose: To investigate the feasibility of a new oxygen delivery device, the "Right Dose System" (RDS). It delivers individualized boluses of oxygen during rest and exertion to maintain acceptable oxygen saturations. The procedures include: Enrollment of 10 patients, who are randomized to either exercise with their oxygen prescription followed by exercise with the RDS, or exercise with the RDS followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis. Each set of exercise will be separated by a 30 minute recovery session. Subjects will be adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will be above 18 years of age. Subject participation will last approximately 1 month. Subjects will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation program. Consent will take place in the pulmonary clinic, pulmonary function lab or pulmonary rehabilitation by trained study physicians. If Multi-center: N/A (single center) If Single center or investigator-initiated: 10 subjects will participate in the study.
The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems. The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit. A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%.
This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.
This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.
Objectives: The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator, portable devices filled at home from a concentrator, and medical grade compressed oxygen (either an M6 size or D size cylinder). Hypothesis: Patients who are prescribed LTOT will show similar physiologic responses to exercise when using differing modalities of portable oxygen delivery systems.
Infants of \< 1500 grams of birth weight who require a \> 1 week mechanical ventilation (breathing machine) or CPAP \[continuous positive airway pressure\] (oxygen at a high flow through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through the nose at a low flow) is the most commonly used method of oxygen administration, despite a lack of data regarding its safety and efficacy. Low birth weight infants are vulnerable to obstruction from secretions and blood, as well as the presence of the nasal cannula. Partially obstructed nostrils greatly increase the work of breathing. Additional potential adverse effects include an increased need for suctioning, increased risk for systemic infection, and inadvertent positive end expiratory pressure (CPAP). No study has been conducted to evaluate the efficacy of the nasal cannula compared to an oxygen hood (plastic "hood" that is placed over the infant's head to provide oxygen) on gas exchange or infection. Among infants who require supplemental oxygen (by either a nasal cannula or an oxygen hood) for clinical indications, objectives the investigators hope to accomplish in a randomized blinded (investigator) trial: Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula on transcutaneous PCO2 (PTCO2). Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one week) use of a nasal cannula compared to an oxygen hood on PTCO2.
In neonates and infants \</= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.
The purpose of this study is to extend our previous work, in which we demonstrated an increase in the internal and cross network connectivity of resting state neural networks in patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least 20 more individuals.
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regard to the patient's fluid status and management of additional fluids and medications. As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management. This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring during CRRT therapy.
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications. As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management. This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
The purpose of this study is to determine if, in preterm infants \< 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention. This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.
The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.
The purpose of this study is to determine if giving blood transfusions to anemic patients with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.
The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath. The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.
The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and to possibly reduce associated multi-system organ related dysfunction. In attempting to design a trial comparing higher versus lower oxygen during neonatal resuscitation with the potential for benefit to the enrolled infants, and a minimal level of risk, and acknowledging that the use of Room Air may be considered premature in view of the lack of any safety data in this population, we are proposing to utilize an oxygen blender and a pulse oximeter in the delivery room in the treated group. The treated group will have their fraction of inspired oxygen increased from 21%, as necessary, to achieve a target oxygen saturation of 85 to 90% at 5 minutes of life, compared with the standard of care group who will receive 100% oxygen without the use of a blender, which is the current approach in most centers in this country. The targeted saturation of 85% will provide enough oxygen to treat any ventilation/perfusion mismatch, while exposing the infants to significantly less inspired oxygen. Hypothesis: We hypothesize that the use of restricted inspired oxygen during resuscitation will result in a significant reduction in oxidant stress without any harmful clinical effects.
This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.
The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.