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Status unknownNCT05216640Updated Jan 31, 2022

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

An interventional study of High Flow Oxygen Therapy in COVID-19 and Acute Respiratory Failure, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Assiut University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • COVID-19
  • Acute Respiratory Failure

Keywords

  • HFNC
  • HVNI
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    High Flow Nasal Cannula

    Standard operating procedures represented by high flow nasal cannula oxygen therapy

    Device: High Flow Oxygen Therapy

  • Active comparator
    High Velocity Nasal Insufflation

    Standard operating procedures represented by high velocity nasal insufflation therapy

    Device: High Flow Oxygen Therapy

Interventions

  • DeviceHigh 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

06

What researchers measure

Primary outcomes

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

    need for mechanical ventilation

    Time frame: baseline

  2. changes of arterial blood gases (ABG) parameters

    changes of arterial blood gases (ABG) parameters

    Time frame: within 2 hours then according to clinical condition

  3. duration of ventilatory support

    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

  4. delay between admission and intubation.

    delay between admission and intubation.

    Time frame: baseline

Secondary outcomes

  1. To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients

    duration of ICU stay

    Time frame: baseline

  2. mortality rate

    mortality rate

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32134116 ↗
  • 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. PubMed 32091533 ↗
  • 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. PubMed 32222812 ↗
  • 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. PubMed 27016353 ↗
  • 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. PubMed 29310868 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05216640
Lead sponsor
Assiut University
Responsible party
Basma Abd ElAziz Mohammed (Resident doctor, Assiut University) — Principal investigator
First posted
Jan 31, 2022
Start date
Mar 2022 (estimated)
Primary completion
Mar 2023 (estimated)
Completion
May 2023 (estimated)
Last update
Jan 31, 2022

Study contacts

Basma A Mohammed, MD
Contact
Basma.20133938@med.au.edu.eg
+0201067620044
Hoda A Makhlouf, MD
Contact
hamakhlouf@yahoo.com
+0201001529442
Maha k Ghanem, MD
study director · Assuit university, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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