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

Study Overview
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Brief Summary
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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
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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

Official Title
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High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19 Patients Admitted to Respiratory Intensive Care Unit of Assiut University Hospital

Conditions
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COVID-19, Acute Respiratory Failure

Intervention / Treatment
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* Device: High Flow Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure | need for mechanical ventilation | baseline | 
| changes of arterial blood gases (ABG) parameters | changes of arterial blood gases (ABG) parameters | within 2 hours then according to clinical condition | 
| duration of ventilatory support | duration of ventilatory support | 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 | 
| delay between admission and intubation. | delay between admission and intubation. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients | duration of ICU stay | baseline | 
| mortality rate | mortality rate | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HVNI, HFNC