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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05216640
Recruitment Status : Not yet recruiting
First Posted : January 31, 2022
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Basma Abd ElAziz Mohammed, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Failure Device: High Flow Oxygen Therapy Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High Flow Nasal Cannula
Standard operating procedures represented by high flow nasal cannula oxygen therapy
 Device: High Flow Oxygen Therapy
• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI
Active Comparator: High Velocity Nasal Insufflation
Standard operating procedures represented by high velocity nasal insufflation therapy
 Device: High Flow Oxygen Therapy
• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI


Outcome Measures
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Primary Outcome Measures :
  1. To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure [ Time Frame: baseline ]
    need for mechanical ventilation

  2. changes of arterial blood gases (ABG) parameters [ Time Frame: within 2 hours then according to clinical condition ]
    changes of arterial blood gases (ABG) parameters

  3. 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 ]
    duration of ventilatory support

  4. delay between admission and intubation. [ Time Frame: baseline ]
    delay between admission and intubation.


Secondary Outcome Measures :
  1. To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients [ Time Frame: baseline ]
    duration of ICU stay

  2. mortality rate [ Time Frame: baseline ]
    mortality rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216640


Contacts
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Contact: Basma A Mohammed, MD +0201067620044 Basma.20133938@med.au.edu.eg
Contact: Hoda A Makhlouf, MD +0201001529442 hamakhlouf@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Maha k Ghanem, MD Assuit university, Egypt
More Information
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Publications:

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Responsible Party: Basma Abd ElAziz Mohammed, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT05216640    
Other Study ID Numbers: HFNC VS HVNI in COVID 19
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Basma Abd ElAziz Mohammed, Assiut University:
HFNC
HVNI
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders