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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05216640
Collaborator
(none)
50
2
14

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: High Flow Oxygen Therapy
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure [baseline]

    need for mechanical ventilation

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

    changes of arterial blood gases (ABG) parameters

  3. 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]

    duration of ventilatory support

  4. delay between admission and intubation. [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 [baseline]

    duration of ICU stay

  2. mortality rate [baseline]

    mortality rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Resident doctor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022