HFNT vs. COT in COVID-19

NCT04655638 | Completed DMC

• 1 other identifier: 1th Dec 2020
• Study Type: interventional
• Target: 364
• Locations: 6 countries
• Sites: 27

Brief Summary

The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.

Conditions

Covid19; Acute Respiratory Failure

Keywords

COVID-19; HFNT; Respiratory failure; COT; Oxygen; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients needing escalation of treatment during hospital stay

  Proportion of patients needing escalation of treatment (i.e. noninvasive ventilation - including CPAP - or intubation).

  28 days

Secondary Outcomes (19)

• Proportion of patients needing intubation during hospital stay

  28 days

• Proportion of patients who receive CPAP during hospital stay

  28 days

• Proportion of patients who receive NIV during hospital stay

  28 days

• Proportion of patients admitted to intensive care unit during hospital stay

  28 days

• Proportion of patients who terminate the study protocols for improvement

  28 days

Study Arms (2)

High Flow Nasal Therapy

EXPERIMENTAL

High flow nasal therapy

Device: High Flow Nasal Therapy

Conventional Oxygen Therapy

ACTIVE COMPARATOR

Conventional Oxygen therapy

Device: Conventional Oxygen Therapy

Interventions

High Flow Nasal Therapy DEVICE

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%.

High Flow Nasal Therapy

Conventional Oxygen Therapy DEVICE

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%.

Conventional Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• 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.

You may not qualify if:

• PaO2/FiO2 ≤ 200
• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead
• Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele: collaborator

Study Sites (27)

Department of Anesthesiology, University of Thessaly, School of Health Sciences, Faculty of Medicine

Larissa, Greece

Location

Department of Emergency Medicine, Faculty of Medicine, University of Thessaly

Larissa, Greece

Location

UO di Pronto Soccorso e Medicina d'Urgenza Humanitas Research Hospital

Rozzano, Milano, Italy

Location

U.O. di Medicina interna AULSS 7 Pedemontana

Bassano del Grappa, VI, Italy

Location

Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy

Arezzo, Italy

Location

Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari

Bari, Italy

Location

Ospedale di Carpi

Carpi, Italy

Location

Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital, Catania, Italy

Catania, Italy

Location

UO di Medicina d'Urgenza AOU Policlinico Vittorio Emanuele San Marco di Catania

Catania, Italy

Location

Respiratory Section, Department of Translational Medicine, University of Ferrara. AOU Ferrara Arcispedale S. Anna. U.O. Pneumologia

Ferrara, Italy

Location

Department of Medical and Surgical Sciences, University of Foggia. Institute of Respiratory Diseases, University Hospital 'Policlinico Riuniti'

Foggia, Italy

Location

UO di Pneumologia ASST Fatebenefratelli Sacco

Milan, Italy

Location

AO DEI COLLI - PO Monaldi UO di Pneumologia e Fisiopatologia Respiratoria

Napoli, Italy

Location

AOU San Luigi Gonzaga

Orbassano, Italy

Location

Emergency Department, "S. Maria della Misericordia" Hospital, Perugia, Italy.

Perugia, Italy

Location

U.O. di Pneumologia Azienda USL di Pescara

Pescara, Italy

Location

UO di Pronto Soccorso e Medicina d'Urgenza AUSL Romagna PO Rimini Ospedale "Inferni"

Rimini, Italy

Location

U.O. di PneumoCovid Azienda Ospedaliera San Giovanni di Roma

Roma, Italy

Location

UO di Pneumologia Ospedale S. Bartolomeo

Sarzana, Italy

Location

Department of Pneumology, A.O.U. Città della Salute e della Scienza of Turin, Italy.

Turin, Italy

Location

U.O. di Pneumologia ASST Settelaghi Ospedale Circolo Fondazione Macchi

Varese, Italy

Location

U.O. Medicina Respiratoria del Policlinico G.B. Rossi

Verona, Italy

Location

U.O. di Pneumotisiologia Ospedale di Vittorio Veneto Azienda ULSS 2 Marca Trevigiana

Vittorio Veneto, Italy

Location

Department of Pneumonology, Faculty of Medical Sciences in Katowice, Medical University of Silesia

Katowice, Poland

Location

Hospital Prof. Doutor Fernando Fonseca, Pneumologia

Amadora, Portugal

Location

Hospital Parc Taulí de Sabadell, Pneumologia

Sabadell, Spain

Location

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 33201321 BACKGROUND

• 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.

  PMID: 32756535 BACKGROUND

• 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.

  PMID: 32224769 BACKGROUND

• 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.

  PMID: 29368599 BACKGROUND

• 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.

  PMID: 35580898 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Andrea Cortegiani, MD

  University of Palermo. Azienda Ospedaliera Policlinico Paolo Giaccone

  PRINCIPAL INVESTIGATOR

• Claudia Crimi, MD

  Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Unblinded parallel-group randomized multicenter clinical trial

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 7, 2020
• Study Start: February 10, 2021
• Primary Completion: September 22, 2021
• Study Completion: October 25, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

PL (1); ES (1); GR (2); PT (1); IT (21); TU (1)