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

January 28, 2022 updated by: Basma Abd ElAziz Mohammed, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Time Frame: baseline
need for mechanical ventilation
baseline
changes of arterial blood gases (ABG) parameters
Time Frame: within 2 hours then according to clinical condition
changes of arterial blood gases (ABG) parameters
within 2 hours then according to clinical condition
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
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.
Time Frame: baseline
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
Time Frame: baseline
duration of ICU stay
baseline
mortality rate
Time Frame: baseline
mortality rate
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Maha k Ghanem, MD, Assuit university, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

November 13, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNC VS HVNI in COVID 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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