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drug2616 | Sevoflurane inhalant product Wiki | 1.00 |
drug3484 | survey Wiki | 0.41 |
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There is one clinical trial.
Around1 in 4 COVID-19 patients suffer lung failure needing life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines. Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies. This research is a study being carried out in a number of hospitals that will compare how well patients recover from this illness depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for COVID-19 patients who need lifesaving treatments.
Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant hospital mortality as compared to standard intravenous sedation regimen with a 10% difference between groups for 752 participants.
Measure: Hospital Mortality Time: 2 yearsDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant ventilation outcomes after 30 days post enrollment, as compared to standard intravenous sedation regimen for 200 participants
Measure: Ventilator-Free Days Time: 30 daysDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant time spent in ICU, 30 days post enrollment, as compared to standard intravenous sedation regimen for 128 participants
Measure: ICU-Free Days Time: 30 daysDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant quality of life outcomes at 3 and 12 months post discharge as compared to standard intravenous sedation regimen for 144 participants. The EQ-5D questionnaire will be completed at both time points
Measure: Participant Quality of Life at 3 and 12 months after discharge Time: 365 daysDescription: To evaluate participant median daily oxygenation (PaO2/FiO2) at 3 days post enrollment
Measure: Median Daily Oxygenation Time: 3 daysDescription: To evaluate participant need for adjunctive ARDS therapies (prone, nitric oxide, paralysis, ECMO) during ICU stay
Measure: Adjunctive ARDS therapies Time: 30 daysDescription: To evaluate the number of hospital-free days for participants, 60 days after enrollment
Measure: Hospital-Free Days Time: 60 daysDescription: To evaluate participant disability at 3 and 12 months post discharge. The World Health Organization Disabiltity Assessment Score (WHODAS 2.0) will be completed at both timepoints. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items.
Measure: Disability Time: 365 daysDescription: Quality of Life (QALY) assessment to be calculated using the EQ-5D, comparison costs at 3 and 12 months post discharge, costs associated with hospital stay, devices and sedative costs
Measure: Cost Utility Analysis Time: 365 daysDescription: Life Year Gained (LYG) to be calculated using the EQ-5D, total costs during hospitalization, and health care utilization for 1 year after discharge.
Measure: Cost Effectiveness Analysis Time: 365 days