728 Clinical Trials for Various Conditions
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Klippel-Feil syndrome (KFS) was first described in 1912 by Klippel and Feil as a classic triad are comprised of a short neck, a low posterior hairline and restricted motion of the neck. This disease is considered as one of the congenital causes of difficult airway with the incidence of 1:42,000 live births. The current research findings suggested that the difficulties of airway management for KFS increases with age. In pediatric patients, the airway of those patients can be managed without difficulties. For adults, the fiberoptic-assisted intubation is also suggested. The purpose of this study is to review the airway management of pediatric patients with KFS to provide recommendation of airway management for these patients. A retrospective electronic chart review will be conducted by using Boston Children's Hospital (BCH) database, which identified patients with KFS who had undergone general anesthesia from June 2012 to June 2018.
The goal of this study is to track the intraoperative changes that occur in the airways of patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal surgeries in the prone position, as well as the regression of these changes postoperatively. These surgeries are known to cause edema and swelling of the soft tissues of the head and neck, temporarily worsening airway anatomy, but there is little data quantifying these changes, and no studies have investigated the time course required for the airway to return to its baseline after extubation. This would be important clinical information given that airway management is always a major concern perioperatively. The investigators will test hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of a difficult intubation) based on the visibility of the soft palate, uvula, and faucial pillars inside the oral cavity.
We will investigate the impact biohazard gear has on time to successful intubation and, in particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus, Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video) intubation techniques.
A laryngeal mask airway ("LMA") is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an "endotracheal tube" (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the "working" end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the "ELLIA" method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.
The overall purpose of this study is to assess the impact of preclinical airway manikin training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) on the clinical learning curve of using the device/system in airways with predictors for difficult intubation. The investigators hypothesize that the clinical learning curve in airways with predictors for difficult intubation will be shorter for study subjects (operators) who undergo preclinical manikin training under simulated difficult airway conditions compared to Study subjects (operators) who do not receive this training. The clinical learning curve is characterized by procedure times and first attempt success rates on successive uses of the Airtraq Avant and Wireless Monitor System in patients with at least one predictor for difficult intubation.
Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.
Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy cardiovascular system, maintain brain function, reduce depression, and improve inflammatory diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced bronchoconstriction and airway inflammation as compared to placebo.
Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.
Combining fish oil supplementation and Montelukast \[a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)\] will provide a greater antiinflammatory effect against developing EIB that either agent alone
Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma.
Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).
The purpose of this study is to investigate which flow rate (higher versus lower) is most effective at increasing apneic time and preventing greater than 5% drop in desaturation, as well as assessing transcutaneous carbon dioxide (CO2) levels during airway procedures in children
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
The FASTER stabilizing rod offers the distinct advantage of intubating through the laryngeal mask airway with a fiberoptic scope via the FASTER stabilizing rod. The device allows for the provider to insert the endotracheal tube (ETT) with visual confirmation using the fiberoptic scope into the trachea. The device then allows for the laryngeal mask airway to be removed while stabilizing the ETT to ensure the ETT does not get dislodged. The purpose of this protocol is to clinically test the validated prototype that the investigators have built and previously tested in adults with obesity. The primary aims are to evaluate 1) the time to intubation and 2) the number of intubation attempts. The secondary aim is to note any complications from time to intubation to PACU discharge. These complications include: Hypoxemia (10% decrease from baseline for 45 seconds)1 Airway trauma (minor) Esophageal intubation Laryngospasm Bronchospasm Oro-pharyngeal bleeding Arrythmia Emesis Epistaxis Dental damage Post-operative sore throat Post-operative hoarseness Accidental extubation during removal of the LMA.
The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
The purpose of the study is to assess the propellants,1 - Difluoroethane \[HFA-152a\] (Test) and 1,1,1,2-Tetrafluoroethane \[HFA-134a\] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.
This study using a Delphi methodology, and involving international experts, will help define a training curriculum for physicians involved with airway management in critically ill patients.
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma. Study details include: * The study duration will be up to 15 weeks. * The treatment duration will be 12 weeks. * The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).
The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.
The goal of this clinical trial is to compare the overall performance and patient outcomes of two video-assisted laryngeal mask airways (VLMAs) devices called Safe and Comfortable (SaCo) VLM and SafeLM® (Safe VLM) versus video laryngoscopy for airway management in adult patients, without an anticipated difficult airway, that are undergoing elective general anesthesia procedures. The main question it aims to answer is: Can both VLMAs improve patient-centered outcomes in the perioperative and postoperative periods in comparison to endotracheal tube (ETT) intubation? Thirty participants will undergo randomized VLMA with either the Safe VLM (15 participants) or the SaCo VLM (15 participants). And 15 participants will be intubated with ETT using video laryngoscopy, as the control group. Researchers will evaluate the efficacy of these two video-assisted devices in adult patients without an anticipated difficult airway in elective general anesthesia procedures. Other patient outcomes and exploratory endpoints will be recorded as well.
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\].
This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.
The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are: * What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group? * What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system. 4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.
Airway swelling and edema after cervical spine surgery(CSS) especially in prone position is the direct cause that prohibits patient from extubation. Anterior cervical discectomy and fusion causes severe peri-vertebral soft tissue swelling that was associated with increased postoperative airway complications. Facial, lip and tongue edema in combination with the cuff leak test and risk factors are currently served as the bases on whether patient can be extubated after spine surgery. Direct visualization of the larynx and inside trachea post-operatively to assess the airway directly using flexible fiberoptic scope as well as to quantify the degree of airway edema has not been investigated. Investigators are comparing airway before and after cervical spine surgery for any degree of narrowing in the airway using flexible fiberoptic scope. Investigators are also studying the risk factors affecting the degree of narrowing in the airway if any