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

NCT ID: NCT05216640

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-05-31

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

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

Conditions

COVID-19; Acute Respiratory Failure

Keywords

HFNC; HVNI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

High Flow Nasal Cannula

Standard operating procedures represented by high flow nasal cannula oxygen therapy

Group Type: ACTIVE_COMPARATOR

High Flow Oxygen Therapy

Intervention Type: DEVICE

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

High Velocity Nasal Insufflation

Standard operating procedures represented by high velocity nasal insufflation therapy

Group Type: ACTIVE_COMPARATOR

High Flow Oxygen Therapy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Basma Abd ElAziz Mohammed

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha k Ghanem, MD

Role: STUDY_DIRECTOR

Assuit university, Egypt

Central Contacts

Basma A Mohammed, MD

Role: CONTACT

Phone: +0201067620044

Email: Basma.20133938@med.au.edu.eg

Hoda A Makhlouf, MD

Role: CONTACT

Phone: +0201001529442

Email: hamakhlouf@yahoo.com

References

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.

Reference Type: BACKGROUND

PMID: 32134116 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32091533 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32222812 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27016353 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29310868 (View on PubMed)

Other Identifiers

HFNC VS HVNI in COVID 19

Identifier Type: -

Identifier Source: org_study_id