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High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19

Primary Purpose

COVID-19, Acute Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Flow Oxygen Therapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring HFNC, HVNI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    High Flow Nasal Cannula

    High Velocity Nasal Insufflation

    Arm Description

    Standard operating procedures represented by high flow nasal cannula oxygen therapy

    Standard operating procedures represented by high velocity nasal insufflation therapy

    Outcomes

    Primary Outcome Measures

    To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure
    need for mechanical ventilation
    changes of arterial blood gases (ABG) parameters
    changes of arterial blood gases (ABG) parameters
    duration of ventilatory support
    duration of ventilatory support
    delay between admission and intubation.
    delay between admission and intubation.

    Secondary Outcome Measures

    To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients
    duration of ICU stay
    mortality rate
    mortality rate

    Full Information

    First Posted
    November 13, 2021
    Last Updated
    January 28, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05216640
    Brief Title
    High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    novel clinical syndrome caused by a previously unknown coronavirus, SARS-Cov-2, was first identified in Wuhan (China) in December 2019. Despite massive efforts to contain viral transmission, a worldwide epidemic has developed from this virus. This disease is presently known as COVID-19 COVID-19 pandemic reached over 45 million confirmed infections and claimed the lives of more than 1.2 million people worldwide. The clinical features of COVID-19 are diverse and range from asymptomatic to critical illness and death. Severe and critical cases represented 14% and 5% of laboratory-confirmed COVID-19 patients and need ICU admission Several non-invasive options exist to support COVID-19 patients with mild or moderate respiratory distress and may reduce the numbers of patients requiring intubation, mechanical ventilation in some severely ill patients such as High flow nasal oxygen (HFNO) High flow nasal oxygen (HFNO) includes high flow nasal cannula and high velocity nasal insufflation. High flow oxygen systems provide oxygen-rich heated humidified gas to the patient's nose at flow levels sufficient to deliver a constant, precisely set high FiO2. Exhalation is to the open air. HFNO reduces dead space, provides low levels of PEEP, and decreases breathing frequency and work of breathing HFNC flow rates reach up to 60 L/min, whereas HVNI delivers flow rates up to 40 L/min due to differing mechanisms of delivery (4). High velocity nasal insufflation (HVNI) utilizes a small-bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Acute Respiratory Failure
    Keywords
    HFNC, HVNI

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Flow Nasal Cannula
    Arm Type
    Active Comparator
    Arm Description
    Standard operating procedures represented by high flow nasal cannula oxygen therapy
    Arm Title
    High Velocity Nasal Insufflation
    Arm Type
    Active Comparator
    Arm Description
    Standard operating procedures represented by high velocity nasal insufflation therapy
    Intervention Type
    Device
    Intervention Name(s)
    High Flow Oxygen Therapy
    Intervention Description
    • The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI
    Primary Outcome Measure Information:
    Title
    To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure
    Description
    need for mechanical ventilation
    Time Frame
    baseline
    Title
    changes of arterial blood gases (ABG) parameters
    Description
    changes of arterial blood gases (ABG) parameters
    Time Frame
    within 2 hours then according to clinical condition
    Title
    duration of ventilatory support
    Description
    duration of ventilatory support
    Time Frame
    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
    Title
    delay between admission and intubation.
    Description
    delay between admission and intubation.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients
    Description
    duration of ICU stay
    Time Frame
    baseline
    Title
    mortality rate
    Description
    mortality rate
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basma A Mohammed, MD
    Phone
    +0201067620044
    Email
    Basma.20133938@med.au.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hoda A Makhlouf, MD
    Phone
    +0201001529442
    Email
    hamakhlouf@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maha k Ghanem, MD
    Organizational Affiliation
    Assuit university, Egypt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32134116
    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.
    Results Reference
    background
    PubMed Identifier
    32091533
    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. No abstract available.
    Results Reference
    background
    PubMed Identifier
    32222812
    Citation
    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). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
    Results Reference
    background
    PubMed Identifier
    27016353
    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.
    Results Reference
    background
    PubMed Identifier
    29310868
    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.
    Results Reference
    background

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    High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19

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