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

NCT05216640 | Unknown

• 1 other identifier: HFNC VS HVNI in COVID 19
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

COVID-19; Acute Respiratory Failure

Keywords

HFNC; HVNI

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

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

  baseline

• mortality rate

  baseline

Study Arms (2)

High Flow Nasal Cannula

ACTIVE COMPARATOR

Standard operating procedures represented by high flow nasal cannula oxygen therapy

Device: High Flow Oxygen Therapy

High Velocity Nasal Insufflation

ACTIVE COMPARATOR

Standard operating procedures represented by high velocity nasal insufflation therapy

Device: High Flow Oxygen Therapy

Interventions

High Flow Oxygen Therapy DEVICE

• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI

High Flow Nasal Cannula; High Velocity Nasal Insufflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 32134116 BACKGROUND

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32222812 BACKGROUND

• 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.

  PMID: 27016353 BACKGROUND

• 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.

  PMID: 29310868 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maha k Ghanem, MD

  Assuit university, Egypt

  STUDY DIRECTOR

Central Study Contacts

Basma A Mohammed, MD

CONTACT

+0201067620044; Basma.20133938@med.au.edu.eg

Hoda A Makhlouf, MD

CONTACT

+0201001529442; hamakhlouf@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: January 31, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share