80 Clinical Trials for Various Conditions
The purpose of this study is to: 1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. 2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.
This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease. This study is funded by the FDA Office of Orphan Products Development (OOPD).
Fentanyl is the most commonly used opioid during anesthesia at Massachusetts General Hospital. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyl's pharmacokinetic properties are more problematic as the context sensitive half-time increases with duration of fentanyl infusion. This may lead to respiratory complications particularly in patients who receive fentanyl for surgical procedures of long duration. Considering the common use of fentanyl during surgery and its duration of action that is hard to predict during long surgical procedures, we will evaluate the association between intraoperative fentanyl dose and postoperative respiratory complications within 3 days of surgery.
Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.
This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction. Hypotheses: Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.
The purpose of this study is to determine if residual weakness after weight loss surgery leads to an increased risk of respiratory complications in the postoperative period.
This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month. Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development
The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 12 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.
The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients. The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.
The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.
Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.
Postoperative pulmonary complications (PPCs) are a source of much morbidity and mortality. Rates of PPCs exceed 30% in patients with multiple risk factors. Several studies have demonstrated reduced PPCs in patients who underwent preoperative inspiratory muscle training. These studies largely focused on cardiothoracic surgery and required the use of respiratory therapists. The investigators hypothesize that preoperative, self-administered respiratory therapy would reduce PPCs in patients with risk factors for PPCs undergoing any non-cardiothoracic surgery. This study is a randomized, controlled trial comparing preoperative use of an incentive spirometry device with usual care in patients undergoing non-emergent, non-cardiothoracic surgical procedures under general anesthesia.
The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.
In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation). It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected. The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.
Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.
General anesthesia is a treatment with medicine to make a patient unconscious for surgery. This is sometimes called "being put to sleep" or "being put under." Most of the time, a breathing tube is used to help a machine breathe for patients. The breathing tube has a cuff, which is like a small balloon. After the breathing tube is placed, the cuff is inflated. This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from getting into the windpipe and lungs. When a breathing tube is removed, that is called extubation. Normally, doctors deflate the cuff before removing the breathing tube. This is called deflated cuff extubation. Some doctors worry that keeping the cuff inflated while it is removed can damage the throat or vocal cords. However, some doctors keep the cuff inflated when removing the breathing tube. This is called inflated cuff extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering the airway. Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The goal of this study is to see which type of extubation is better at keeping fluids from getting in the airway. Participants who are part of this study will get general anesthesia and have surgery as planned. Near the end of surgery, a small amount of liquid is placed at the back of a participant's mouth. This liquid is called contrast material, and it is like a dye. The contrast material will help determine if any liquid enters the windpipe or lungs. Then, contrast material is removed, along with any other fluids, using normal methods. When it is safe to take the breathing tube out, a deflated cuff extubation or an inflated cuff extubation will be performed. This decision will be made at random, like by the flip of a coin. Information will be collected about participants, the surgery, and how well a participant is breathing. After surgery, a chest x-ray will be taken to see if any of the contrast material is in the windpipe or lungs. Otherwise, everything else after surgery would be normal. 24 to 48 hours after surgery, a member of the research team will ask about any symptoms a participant may have, like sore throat or a hoarse voice. Research would conclude at that time.
This will be a randomized, placebo-controlled, double-blinded, pilot trial with two parallel groups (1:1 ratio) receiving either dexmedetomidine (initial bolus of 1 mcg/kg over 30 min after induction, followed by an infusion rate of 0.3 mcg/kg/hr that will be stopped 30-45 minutes before the end of the surgery or upon reaching maximum dose of 2mcg/kg, whichever comes first) or placebo (normal saline as a bolus followed by maintenance infusion at the same rate of the intervention group). Dexmedetomidine is frequently administered in thoracic surgery. Using local data from the Brigham and Women's Hospital, dexmedetomidine was used in a third of the thoracic procedures performed over the past three years. However, there is no consensus as to the optimal protocol of administration, therefore clinical practice is highly heterogeneous (bolus versus continuous infusion) and mostly depends on the preferences of anesthesia providers. In our institution, the dose of dexmedetomidine is typically 0.5 mcg/kg but varies based on attending preferences and experience. Given the heterogenous practices in dexmedetomidine administration, one of the objectives is to assess the feasibility of adhering to a dexmedetomidine protocol using an initial loading dose of 1 mcg/kg over 30 minutes after induction followed by a continuous infusion of 0.3 mcg/kg/hr. The infusion will stop 30-45 minutes prior to the end of surgery or once a maximum dose of 2mcg/kg has been achieved, whichever comes first. The control group will receive normal saline (similar bolus followed by maintenance infusion at the same rate of the intervention group).
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.
Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success
The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information. A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.
This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung function in patients that were hospitalized for severe COVID-19-related illness and continue to experience post-acute respiratory complications associated with Long-COVID after discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
To determine the efficacy of oscillatory positive expiratory pressure (OPEP) therapy on patients admitted through the trauma service line for rib fractures, as compared to incentive spirometry (IS).