Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome
| Autor: | Ahmed S.A. Soliman, Karimulla S. Shaik, Hani Elzeer, Abdulqadir J. Nashwan, Nevin Kannappilly, Moustafa S. Elshafei, Muhsen A Shahen, Mohamed Z. Peediyakkal, Wael I Abdaljawad, Dore C. Ananthegowda, Mohamad Y. Khatib, Ahmed S. Mohamed |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.medical_treatment facemask law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Informed consent law Study Protocol Clinical Trial Medicine Intubation Humans 030212 general & internal medicine Adverse effect Critical Care Outcomes Positive end-expiratory pressure Randomized Controlled Trials as Topic Mechanical ventilation Respiratory Distress Syndrome Noninvasive Ventilation business.industry non-invasive ventilation helmet Masks General Medicine acute respiratory distress syndrome Length of Stay Middle Aged Intensive care unit Intensive Care Units Treatment Outcome coronavirus disease Clinical Trials Phase III as Topic 030220 oncology & carcinogenesis Emergency medicine Breathing Female Head Protective Devices business Research Article |
| Zdroj: | Medicine |
| ISSN: | 1536-5964 0025-7974 |
| Popis: | The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18âyears old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance. TRIAL REGISTRATION NUMBER: NCT04507802. PROTOCOL VERSION: May 2020. |
| Databáze: | OpenAIRE |
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