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