High Flow Nasal Cannula HFNC In Covid-19 Patients (HFNC19LGH)

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

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Device: High flow nasal cannula HFNC

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54500
      • Recruiting
      • Muhammad Irfan Malik
      • Contact: Sardar Al-Fareed Zafar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group intervene with HFNC; Review effect of HFNC as clinical trial among hospitalized patients with COVID-19 infection.	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.; Other Names: HFNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	Number of days of hospital admission either in ICU or HDUs till date of discharge	15 days
Supplemental Oxygen Requirement from Baseline	Duration of increased supplemental oxygen requirement from baseline	15 days
Duration of intervention	Length of HFNC therapy to COVID-19 patients	15 days
Radiological outcome	Follow up radiological response HR-CT.	15 days

Collaborators and Investigators

• Sponsor: Lahore General Hospital

Publications and helpful links

General Publications

• 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;1(2):95-101. doi: 10.1002/emp2.12071. eCollection 2020 Apr.
• 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.
• 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. No abstract available.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Clinical outcome; High flow nasal cannula HFNC
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: LGH004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No