Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
364 participants
INTERVENTIONAL
2021-02-10
2021-10-25
Brief Summary
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Detailed Description
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The interventions under investigation will be high flow nasal therapy in comparison with conventional oxygen therapy.
HFNT will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. A feeding tube or a nasogastric tube will not represent a contraindication for the use of HFNT provided the patency of the used nostril.
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Co-interventions: Patients potentially eligible for the study will be evaluated by the attending physicians and receive medical therapy based on the attending physician's decision and local protocols. Awake proning is allowed. Local protocols, including drugs and awake proning, will be discussed with the enrolling centers at the initiation visit, and adherence to WHO guidelines will be recommended. Written informed consent from all the patients will be collected.
Termination criteria \& protocol violation: Criteria for weaning off COT or HFNT was at clinical discretion of the managing physician based on the improvement in oxygenation with ability to maintain SpO2 of 96% or greater with less than 0.30 of FiO2 or P/F \> 300. The switch from COT to HFNT should be considered a protocol violation and should be based on clinical decision of the treating physician.
Criteria to be considered for escalation of treatment: 1) SpO2 ≤ 92% despite COT or HFNT or P/F ≤ 180 with FiO2 ≥ 50%, and 2) at least one of the following: respiratory rate ≥ 28 breaths/min, severe dyspnea, signs of increased work of breathing (e.g. use of accessory muscles). If the patient meets these criteria, escalation of treatment CPAP, NIV or IMV will be considered.
The choice of the type of escalating treatment will be a clinical decision of the treating physician.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Flow Nasal Therapy
High flow nasal therapy
High Flow Nasal Therapy
High flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%.
Conventional Oxygen Therapy
Conventional Oxygen therapy
Conventional Oxygen Therapy
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Interventions
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High Flow Nasal Therapy
High flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%.
Conventional Oxygen Therapy
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Eligibility Criteria
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Inclusion Criteria
* Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR) nasopharyngeal swabs
* Clinical signs of acute respiratory infection and radiological evidence of pneumonia
* Hospital admission in any ward or Emergency Department within 48 h
* SpO2 ≤ 92% or PaO2/FiO2 \< 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.
Exclusion Criteria
* Respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles
* Need for immediate intubation or noninvasive ventilation (including CPAP) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis pH ≤ 7.3)
* Patients already on CPAP/NIV or HFNT at study screening
* Septic shock
* Evidence of multiorgan failure
* Glasgow Coma Scale \< 13
* Inability to comprehend the study content and give informed consent
* PaCO2 \> 45 mmHg, (if blood gas available) or history of chronic hypercapnia
* Patient already on long-term oxygen therapy (LTOT) or home NIV/CPAP (even if only overnight)
* Neuromuscular disease
* Limitation of care based on patients' or physicians' decision
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
OTHER
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
OTHER
Responsible Party
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Andrea Cortegiani, MD
Principal Investigator
Principal Investigators
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Andrea Cortegiani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Palermo. Azienda Ospedaliera Policlinico Paolo Giaccone
Claudia Crimi, MD
Role: PRINCIPAL_INVESTIGATOR
Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital
Locations
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Department of Anesthesiology, University of Thessaly, School of Health Sciences, Faculty of Medicine
Larissa, , Greece
Department of Emergency Medicine, Faculty of Medicine, University of Thessaly
Larissa, , Greece
UO di Pronto Soccorso e Medicina d'Urgenza Humanitas Research Hospital
Rozzano, Milano, Italy
U.O. di Medicina interna AULSS 7 Pedemontana
Bassano del Grappa, VI, Italy
Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
Arezzo, , Italy
Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari
Bari, , Italy
Ospedale di Carpi
Carpi, , Italy
Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital, Catania, Italy
Catania, , Italy
UO di Medicina d'Urgenza AOU Policlinico Vittorio Emanuele San Marco di Catania
Catania, , Italy
Respiratory Section, Department of Translational Medicine, University of Ferrara. AOU Ferrara Arcispedale S. Anna. U.O. Pneumologia
Ferrara, , Italy
Department of Medical and Surgical Sciences, University of Foggia. Institute of Respiratory Diseases, University Hospital 'Policlinico Riuniti'
Foggia, , Italy
UO di Pneumologia ASST Fatebenefratelli Sacco
Milan, , Italy
AO DEI COLLI - PO Monaldi UO di Pneumologia e Fisiopatologia Respiratoria
Napoli, , Italy
AOU San Luigi Gonzaga
Orbassano, , Italy
Emergency Department, "S. Maria della Misericordia" Hospital, Perugia, Italy.
Perugia, , Italy
U.O. di Pneumologia Azienda USL di Pescara
Pescara, , Italy
UO di Pronto Soccorso e Medicina d'Urgenza AUSL Romagna PO Rimini Ospedale "Inferni"
Rimini, , Italy
U.O. di PneumoCovid Azienda Ospedaliera San Giovanni di Roma
Roma, , Italy
UO di Pneumologia Ospedale S. Bartolomeo
Sarzana, , Italy
Department of Pneumology, A.O.U. Città della Salute e della Scienza of Turin, Italy.
Turin, , Italy
U.O. di Pneumologia ASST Settelaghi Ospedale Circolo Fondazione Macchi
Varese, , Italy
U.O. Medicina Respiratoria del Policlinico G.B. Rossi
Verona, , Italy
U.O. di Pneumotisiologia Ospedale di Vittorio Veneto Azienda ULSS 2 Marca Trevigiana
Vittorio Veneto, , Italy
Department of Pneumonology, Faculty of Medical Sciences in Katowice, Medical University of Silesia
Katowice, , Poland
Hospital Prof. Doutor Fernando Fonseca, Pneumologia
Amadora, , Portugal
Hospital Parc Taulí de Sabadell, Pneumologia
Sabadell, , Spain
Dokuz Eylül University
Izmir, , Turkey (Türkiye)
Countries
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References
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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. No abstract available.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
Crimi C, Noto A, Cortegiani A, Impellizzeri P, Elliott M, Ambrosino N, Gregoretti C. Noninvasive respiratory support in acute hypoxemic respiratory failure associated with COVID-19 and other viral infections. Minerva Anestesiol. 2020 Nov;86(11):1190-1204. doi: 10.23736/S0375-9393.20.14785-0. Epub 2020 Aug 5.
Alhazzani W, Moller 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). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
Crimi C, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, De Vuono S, Fiorentino G, Pantazopoulos I, Chalkias A, Libra A, Mattei A, Scala R, Clini EM, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial. Thorax. 2023 Apr;78(4):354-361. doi: 10.1136/thoraxjnl-2022-218806. Epub 2022 May 17.
Other Identifiers
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1th Dec 2020
Identifier Type: -
Identifier Source: org_study_id