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

• ClinicalTrials.gov Identifier: NCT05216640
• Recruitment Status: Not yet recruiting
• First Posted: January 31, 2022
• Last Update Posted: January 31, 2022
• Sponsor: Assiut University
• Information provided by (Responsible Party): Basma Abd ElAziz Mohammed, Assiut University

Tracking Information

• First Submitted Date: November 13, 2021
• First Posted Date: January 31, 2022
• Last Update Posted Date: January 31, 2022
• Estimated Study Start Date: March 2022
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2022)

• To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure [ Time Frame: baseline ]
  need for mechanical ventilation
• changes of arterial blood gases (ABG) parameters [ Time Frame: within 2 hours then according to clinical condition ]
  changes of arterial blood gases (ABG) parameters
• 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
• delay between admission and intubation. [ Time Frame: baseline ]
  delay between admission and intubation.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 28, 2022)

• 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
• mortality rate [ Time Frame: baseline ]
  mortality rate

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19
• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• COVID-19
• Acute Respiratory Failure

Intervention

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

Study Arms

• Active Comparator: High Flow Nasal Cannula
  Standard operating procedures represented by high flow nasal cannula oxygen therapy
  Intervention: Device: High Flow Oxygen Therapy
• Active Comparator: High Velocity Nasal Insufflation
  Standard operating procedures represented by high velocity nasal insufflation therapy
  Intervention: Device: High Flow Oxygen Therapy

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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 28, 2022): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Basma A Mohammed, MD; +0201067620044; Basma.20133938@med.au.edu.eg

Contact: Hoda A Makhlouf, MD; +0201001529442; hamakhlouf@yahoo.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05216640
• Other Study ID Numbers: HFNC VS HVNI in COVID 19
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Basma Abd ElAziz Mohammed, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assiut University
• Verification Date: January 2022