62 Clinical Trials for Various Conditions
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are: * Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements. * Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.
This pilot study tests the feasibility of using a computerized ventilator management protocol seeking to encourage lung protective ventilation during the acute phase of ventilation, and esophageal manometry based titration of ventilator settings during the weaning phase of ventilation, for children with acute respiratory failure. The investigators hypothesize that such an approach will reduce time on mechanical ventilation, largely by preserving diaphragm muscle function.
The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.
This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.
Many extremely premature infants, born before 28 weeks' gestation age, require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.
Aerosol delivery during mechanical ventilation has long been a long debated topic. As evidence-based knowledge about the delivery of aerosol to the lungs of mechanically ventilated patients increases, one piece of the puzzle has remained unexplored; measurement of clinically relevant outcomes. The primary aim of this research is to compare clinical outcomes (ventilator-associated events (VAEs), length of stay (LOS) in intensive care unit (ICU), and total days on mechanical ventilation) when using a traditional jet nebulizer versus a newer generation vibrating mesh nebulizer during mechanical ventilation. The secondary aim of this research is to identify source of bacteria by obtaining cultures of each nebulizer and ventilator circuit and plating them for colony growth and identification.
PURPOSE OF EVALUATION: This study will verify \& validate the acceptability of Egret's extended use product as compared to the existing daily change-out product. Based on an extensive in-vitro study, Egret's product confirmed significant kill for both positive and negative gram bacteria. In addition to meeting all of the current product requirements, total aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of use. The current used product will be used as a control group that is to be changed out daily as per current policy. The control group will be tested for total aerobic bacteria counts on the last day of use.
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (\> 24 hours) in critically ill patients who require mechanical ventilation.
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
Mechanical ventilation is a commonly used life-saving hospital procedure for patients with severe breathing difficulty. Some patients have difficulty separating from the ventilator and need to be removed gradually. This process is called ventilator weaning. It is not known what is the best way to wean patients from the ventilator. In this study, the investigators will compare two commonly used ventilator weaning strategies and compare their success. One ventilator strategy, the Pressure Support Ventilation weaning (PSV), combines 12 hours ventilator weaning with 12 hours rest on the ventilator. This strategy is faster with an anticipated weaning in 2 weeks. The other strategy, the Therapist implemented Patient Specific weaning (TIPS), gradually lowers support and weans in 3 weeks. Patients admitted to Barlow Respiratory Hospital (BRH) for ventilator weaning will be asked to participate in this study within 72 hours of hospital admission. Participants will undergo a spontaneous breathing trial (SBT) to assess your ability to breathe while receiving minimal or no ventilator support. Patients who pass SBT will be eligible for cool aerosol trials (humidified, oxygenated air without positive pressure mechanical ventilation). Participants who fail SBT within 24 hours will be eligible for the study. Participants will be randomized to receive PSV or TIPS ventilator weaning. The investigators will collect clinical, laboratory and mechanical ventilator information throughout the study period. Ventilator weaning success will be compared at day 30. The study will not interfere with any components of clinical care but the study investigators will be allowed to change the ventilator weaning strategy from PSV to TIPS, if a participant is unable to tolerate PSV weaning.
The mortality rates associated with COVID-19 related ARDS (COVIDARDS) have varied from observational reports from around the world. This has ranged from 44% (28 day mortality) in the UK to 36% (28 day mortality from ICU admission) in Italian studies, to 32% (all-cause 28 day mortality) in Spain. Predictive models have identified risk factors for COVID-19 hospitalized patients' mortality to include male sex, obesity, age, obesity, comorbidities including chronic lung disease and hypertension, as well as biomarkers including high levels of D-Dimer, LDH and CRP. In addition, practice patterns, such as drugs that were administered, timing of mechanical ventilation and adherence to established lung protective ventilation protocols are known to be variable across sites and have changed over time. The investigators propose to analyze outcomes for patients with COVIDARDS within the NorthCARDS dataset (a dataset of over 1500 patients with COVID-19 related ARDS across the Northwell Health System in the NYC metropolitan region and Long Island, NY) to understand differences in hospital survival and in the time to liberation from mechanical ventilation, specifically looking at the associations between baseline patient factors, changes in biomarkers, respiratory function and hemodynamics over time, and treatments administered. The analyses will be based on three hypotheses: H.1. Worsening trajectories of: oxygenation index (OI), respiratory system compliance (C), and inflammatory markers will be associated with lower hospital survival. H.2. Higher duration of deep sedation and paralytics will be associated with greater time to liberation from mechanical ventilation. This risk will be increased in patients with worsening trajectories of OI, C, and inflammatory markers over time. H.3. Type of mechanical ventilator, specifically the time on portable mechanical ventilator, is associated with hospital mortality and with inability to liberate from mechanical ventilator despite controlling for risk factors of changes in OI, C and Inflammatory markers over time, and the use of paralytics and deep sedation.
Typically doctors adjust the settings on the ventilator to ensure that children receive enough help to decrease the work they perform to breathe, receive enough oxygen through the machine to pass into the blood and to the organs, and remove acid that builds up in the blood. However, sometimes the settings we choose can result in damage to the lungs. We are trying to find a better way to determine the best ventilator settings, which can minimize potential damage to the lungs, and still provide children with enough support to decrease the work they have to do to breathe. We believe we can personalize these choices for each child by looking at the pressure that is generated in the chest while children breathe with the ventilator. This is accomplished by using a small tube which goes through the nose and into the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor pressure. This same tube can then also be used to monitor how much work children need to do to breathe as we are turning down the ventilator in preparation to remove the breathing tube.
Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed. The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.
This study involves conducting a telephonic or in person survey regarding parental perception and attitudes about vaccinating the respective "technology dependent" child with the COVID 19 vaccination. "Technology dependent" includes tracheostomy dependence, artificial ventilator dependence and non invasive mechanical ventilation dependence. This population is vulnerable since most patients have underlying lung disease, chronic respiratory failure and require respiratory equipment to assist with breathing. "Technology dependent" patients are particularly vulnerable to respiratory infections and are considered high risk for developing severe COVID 19 illness. Despite this population's high risk for morbidity and mortality from respiratory viral infections, the investigator hypothesize that 50% of the parents are still vaccine hesitant.
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.
This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score.
Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
The overall purpose to the study is to prospectively study how often patients with and without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked breaths. The investigators seek to describe the quantity of stacked breaths by continuously recording flow, volume, and pressure waveforms routinely displayed on the vent. The investigators also seek to describe how primary ICU teams manage asynchrony documenting interventions of sedation or vent manipulation and what modality is most successful.
The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to first successful spontaneous breathing trial in mechanically ventilated patients in the medical intensive care unit. Secondary aims of this study are to evaluate the use endotracheal tube sweeping compared to closed suctioning effect on length of mechanical ventilation, length of ICU stay, length of total hospital stay, and occurrence of ventilator-associated events.
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs. This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics. Goals: 1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis. 2. Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes. 3. To determine a return on investment (ROI) for a software system like RKP.
The purposes of our study are to: 1) determine the incidence of paradoxical response to chest wall loading in mechanically ventilated patients; 2) identify sub-populations in which it is most likely to occur (e.g., severe ARDS); and 3) standard the bedside procedure for demonstrating this physiology.
Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone. The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups.
The goal of this study is to compare two different ways of helping patients with a condition called sepsis who need help breathing using a machine called a ventilator. The investigators want to study which way of setting the ventilator is better for the lungs. Here are the main questions the investigators want to answer: 1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. How does the way air spreads out in different parts of the lungs differ between the two ways? In this study, the investigators will take special pictures of the lungs using a machine called a CT scan. The pictures will show us how much the lungs stretch and how much air is in different parts of the lungs. The investigators will compare two different ways of using the ventilator: one personalized for each patient based on their breathing, and another way that is commonly used. By comparing these two ways, the investigators hope to learn which one is better for helping patients with sepsis who need the ventilator. This information can help doctors make better decisions about how to care for these patients and improve their breathing.
The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.