[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-invasive-ventilation-support\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-invasive-ventilation-support":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100598472","phase-2-a-clinical-trial-of-early-ventilation-in-amyotrophic-lateral-sclerosis-event-als-100598472",false,"NCT07071935","A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","A Pilot Randomized Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","EVENT ALS","Inclusion Criteria:\n\n* Diagnosed with ALS using the Gold Coast Criteria within the last 6 months\n* Age ≥18 years\n* Willingness and ability to participate in study procedures\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Current or prior or recommended\u002Fprescribed use of NIV including:\n\n   i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or \"CPAP\" therapy\n2. Forced vital capacity \\\u003C50% of predicted normal\n3. Maximal inspiratory pressure \\> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)\n4. Chronic use of supplemental oxygen at any part of the day\n5. Enrollment in hospice\n6. Current tracheostomy\n7. Prior history of sleep apnea where non-invasive ventilation was used or recommended\n8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks\n9. Coughing up blood\n10. Myocardial infarction in the previous 4 weeks\n11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)\n12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time.\n\nThe investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day.\n\nIn this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study.\n\nThe purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.",[27,28,29,30,31,32,33,34,35,36],"Amyotrophic Lateral Sclerosis (ALS)","Chronic Respiratory Failure","Neuromuscular Disease Patients","Neuromuscular Disease","Respiratory Insufficiency","Respiratory Insufficiency Requiring Mechanical Ventilation","Positive Pressure Ventilation","Non-invasive Ventilation","Non-invasive Ventilation Support","Non-invasive Ventilatory Support",[38,39,40,41],"chronic respiratory failure","chronic neuromuscular respiratory failure","non-invasive ventilation","amyotrophic lateral sclerosis","RECRUITING","2026-06-25",{"date":45,"type":46},"2026-06-26","ACTUAL",{"date":48,"type":46},"2026-06-11",{"date":50,"type":21},"2029-05",{"name":52,"class":53},"University of Pennsylvania","OTHER",3,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100549638","comparison-of-nasal-continuous-positive-airway-pressure-cpap-mask-and-nasal-airway-in-molar-tooth-extraction-under-deep-sedation-100549638","NCT06436638","Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation","Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Terms of Intraoperative Anesthesia Quality and Postoperative Associated Complications in Impacted Molar Tooth Extraction Patients Under Deep Sedation; A Multi-Center Study","Inclusion Criteria:\n\n* Volunteer adult patients aged 18-60 years\n* Patients scheduled for impacted tooth extraction\n* Cases with surgical time ≥20 minutes and ≤60 minutes\n* American Society of Anaesthesiologists (ASA) physical status I and II patients\n* Patients with BMI≤30\n\nExclusion Criteria:\n\n* Patients under 18 years old-over 60 years old\n* Surgeries with a procedure time over 1 hour or less than 20 minutes\n* American Society of Anaesthesiologists (ASA) physical status III and higher patients\n* Presence of conditions such as mental retardation that impair the patient's ability to make decisions about himself\u002Fherself\n* Patients with respiratory system diseases such as asthma, chronic obstructive pulmonary disease (COPD) or airway hyperreactivity\n* Patients with a condition that severely narrows the nasal passage opening (e.g. adenoid hypertrophy, etc.)\n* Patients with BMI\\>30\n* Patients who refused to participate in the study","60 Years",{"count":64,"type":21},60,"OBSERVATIONAL","In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior.\n\nDuring dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature.\n\nThe aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction.\n\nThe hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction.\n\nIn the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \\>0.8.\n\nThe permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.",[68,35,69,70,71],"Deep Sedation","Nasal Airway","Nasal CPAP Mask","Impacted Molar","2026-03-19",{"date":74,"type":46},"2026-03-20",{"date":76,"type":46},"2024-07-02",{"date":78,"type":21},"2026-06",{"name":80,"class":53},"Gözde Nur Erkan"]