COVID-19 Clinical Trial
Official title:
High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19 Patients Admitted to Respiratory Intensive Care Unit of Assiut University Hospital
To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure as regard need for mechanical ventilation, changes of arterial blood gases (ABG) parameters, duration of ventilatory support and delay between admission and intubation
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - COVID-19 positive by RT-PCR - Age= 18 years - Both gender - Classical radiological lesions of COVID-19 on HRCT chest. - Respiratory rate > 30/ min and not responding to non-rebreather masks. - COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP) Exclusion Criteria: - Age < 18 years - Patients who refuse to participate in the study - Severe respiratory failure requiring invasive ventilatory support - Indication of immediate tracheal intubation - Significant acute progressive circulatory insufficiency - Impaired conscious level - Nasal blockade |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Alhazzani W, Møller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28. — View Citation
Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6. — View Citation
Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577. Review. — View Citation
Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29. Review. — View Citation
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure | need for mechanical ventilation | baseline | |
Primary | changes of arterial blood gases (ABG) parameters | changes of arterial blood gases (ABG) parameters | within 2 hours then according to clinical condition | |
Primary | duration of ventilatory support | duration of ventilatory support | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | |
Primary | delay between admission and intubation. | delay between admission and intubation. | baseline | |
Secondary | To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients | duration of ICU stay | baseline | |
Secondary | mortality rate | mortality rate | baseline |
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