High Flow Nasal Cannula HFNC In Covid-19 Patients

SARS-CoV Infection Clinical Trial

— HFNC19LGH  

Official title:

Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560257
• Other study ID #: LGH004
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2020
• Source: Lahore General Hospital
• Contact: Muhammad Irfan Malik, FCPS
• Phone: 03334367220
• Email: drmirfanmalik[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many non-invasive ventilatory choices are available for COVID-19 patient who are having mild to moderate respiratory distress and their use will decrease the chance of ICU admission, intubation and mechanical ventilation in severe cases of COVID-19. However, all these respiratory supports and oxygen supply devices are aerosol generating and their selection should be precised enough to control nosocomial spread.

High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen. In acute respiratory failure HFNC is proven to be very effective and it also reduced the need of mechanical ventilation in severe patients. Apart from the supply of oxygen, HFNC generating positive airway pressure and decreasing the rebreathing from anatomical dead space.

Prone position is also a save therapy and has been proven to be effective for refractory hypoxia by increasing tidal volume, oxygenation and diaphragmatic functions in ARDS patients. Recent studies showed that prone positioning and HFNC might avoid the prerequisite of intubation in moderate to severe patients of ARDS and as a result it decreases the nosocomial infection in physicians who are doing these aerosol generating procedures.

Description:

This is observational single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. We will protect patient's privacy and obey with the Helsinki Declaration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients of > 18 years of ages, males and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.

• Patients having classical radiological lesions of COVID-19 on X-ray chest or 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:

• Inability to provide consent;

• Severe respiratory failure requiring invasive ventilatory support;

• Indication of immediate tracheal intubation

• Significant acute progressive circulatory insufficiency

• Impaired alertness, confusion, restlessness

• Chest trauma or other contraindication to prone position

• Pneumothorax

• Nasal blockade

• Unable to tolerate high flow oxygen

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS (Severe Acute Respiratory Syndrome)
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Device:
• High flow nasal cannula HFNC
High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen.

Locations

Country	Name	City	State
Pakistan	Muhammad Irfan Malik	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Pinkham M, Tatkov S. Effect of flow and cannula size on generated pressure during nasal high flow. Crit Care. 2020 May 24;24(1):248. doi: 10.1186/s13054-020-02980-w. — View Citation

Richards M, Le Roux D, Cooke L, Argent A. The Influence of High Flow Nasal Cannulae on the Outcomes of Severe Respiratory Disease in Children Admitted to a Regional Hospital in South Africa. J Trop Pediatr. 2020 Dec 1;66(6):612-620. doi: 10.1093/tropej/fmaa024. — View Citation

Tu GW, Liao YX, Li QY, Dong H, Yang LY, Zhang XY, Fu SZ, Wang RL. Prone positioning in high-flow nasal cannula for COVID-19 patients with severe hypoxemia: a pilot study. Ann Transl Med. 2020 May;8(9):598. doi: 10.21037/atm-20-3005. — View Citation

Whittle JS, Pavlov I, Sacchetti AD, Atwood C, Rosenberg MS. Respiratory support for adult patients with COVID-19. J Am Coll Emerg Physicians Open. 2020 Apr 13. doi: 10.1002/emp2.12071. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response of HFNC	The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)	10 days
Secondary	Duration of intervention	Length of HFNC therapy to COVID-19 patients	15 days
Secondary	Duration of hospitalization	Number of days of hospital admission either in ICU or HDUs till date of discharge	15 days
Secondary	Supplemental Oxygen Requirement from Baseline	Duration of increased supplemental oxygen requirement from baseline	15 days
Secondary	Radiological outcome	Follow up radiological response HR-CT.	15 days