This trial is evaluating whether Helmet Non-Invasive Ventilation will improve 3 primary outcomes and 9 secondary outcomes in patients with Respiratory Distress Syndrome. Measurement will happen over the course of Censored at 28 days.
This trial requires 15 total participants across 2 different treatment groups
This trial involves 2 different treatments. Helmet Non-Invasive Ventilation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"Severe respiratory failure can result from a variety of illnesses and is likely to be multifactorial in its underlying causation. A better understanding of the underlying mechanisms of the injury will lead to a better understanding of how to prevent respiratory failure." - Anonymous Online Contributor
"If given aggressive medical treatment, the respiratory failure that is common with severe illness and trauma may be managed with remarkable success. This is particularly so when the patient can be shifted to a specialized respiratory therapy unit." - Anonymous Online Contributor
"Ventilatory support with continuous positive airway pressure may improve survival when compared to continuous positive airway pressure with supplemental oxygen. In addition, a lower peak inspiratory pressure with oxygen compared to oxygen alone is recommended when ventilation with oxygen is given. The use of the non-invasive airway adjuncts laryngeal mask airway (tracheal tube) or oropharyngeal mask airway is associated with improved outcomes." - Anonymous Online Contributor
"In patients presenting to the emergency department with severe respiratory failure, early detection and aggressive respiratory therapy are crucial. The identification and timely treatment of underlying cause are critical for successful management." - Anonymous Online Contributor
"This definition is commonly used in emergency medicine, and its use in clinical trials is appropriate. Whether ventilation for respiratory failure was a primary aim or not, it remains a common issue for patients who require mechanical ventilation. The definition of'respiratory failure' remains valid for clinical trials of ventilators in patients with acute respiratory failure." - Anonymous Online Contributor
"In the United States, an estimated 47,400 people have a respiratory failure-related hospitalization every year. This represents a rate of 10% of all hospitalizations or a mean of 2.8 admissions per 1000 persons/year. These numbers can easily be transformed to more commonly used measures of disease frequency per year based on age and sex, as in the table below: (1) Total incidence of respiratory failure among U.S. adults per year: 47,400 per year; (2) Respiratory rate in hospitalized adults, per 1000 persons/year: 2.8; (3) Respiratory rate in U.S. hospital adults, per 1000 persons/year: 11.76." - Anonymous Online Contributor
"According to this review, the inclusion of a patient in a trial will only improve that patient's disease-free survival if the patient and his or her doctor agree to the clinical trial protocol. It also indicates that clinical trials should focus on trials with more stringent eligibility criteria than have been used until recently because patients with moderate to severe respiratory failure might more often have diseases that would result in a survival benefit from a trial, which may be less effective than standard therapies." - Anonymous Online Contributor
"Overall, helmet NIV was well tolerated. However, it is recommended that inpatient NIV treatment be discontinued if possible before conversion to in-hospital NIV. The NIV delivered in the helmet and non-invasive respiratory support devices may be recommended as alternatives to NIPPV if long-term oxygen-treatment is required for people with severe CHF." - Anonymous Online Contributor
"Helmet NIV is associated with a range of adverse events, common in patients undergoing prolonged or continuous NIV which may be associated with patient fatigue. These include worsening or development of dyspnea and pneumonia. A multidisciplinary care plan should be developed to minimize these events and promote NIV use continuously in the interests of patient safety." - Anonymous Online Contributor
"Most studies use patients with acute respiratory failure associated with multiple organ dysfunction and a low probability of survival. The design of these trials is not well-suited for patients with chronic respiratory failure and no other organ dysfunction. It is therefore relevant to compare helmet non-invasive ventilation in patients with severe acute respiratory failure. In a recent study, findings, we found a low level of evidence for survival advantage of non-invasive ventilation. For the patients with severe acute respiratory failure, there is only low and variable level of evidence that a helmet non-invasive ventilation approach for a minimum of five days had a positive impact on survival." - Anonymous Online Contributor
"helmet non-invasive ventilation achieves a high percentage of weaning from conventional mechanical ventilators, although there is the need for future refinement of technology so that the risk of air leak related to helmet pressure adjustments can be minimized in conjunction with a sufficiently short circuit-time. The high percentage of successful weaning was also shown within the clinical parameters in the current investigation, the primary outcome measure. Further validation, also in a larger patient population, seems advisable. Prospective studies are warranted." - Anonymous Online Contributor
"The use of NIV over time improves the patient's quality of life but does not alter their daily functioning. Results from a recent paper support the routine use of NIV for long-term home care for patients with chronic obstructive pulmonary disease and may reduce admissions to hospital and reduce costs." - Anonymous Online Contributor