High Flow Nasal Cannula HFNC In Covid-19 Patients

NCT04560257 | Unknown DMC

• 1 other identifier: LGH004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome)

Keywords

COVID-19; High flow nasal cannula HFNC; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of intervention

  15 days

• Duration of hospitalization

  15 days

• Supplemental Oxygen Requirement from Baseline

  15 days

• Radiological outcome

  15 days

Study Arms (1)

Group intervene with HFNC

EXPERIMENTAL

Review effect of HFNC as clinical trial among hospitalized patients with COVID-19 infection.

Device: High flow nasal cannula HFNC

Interventions

High flow nasal cannula HFNC DEVICE

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.

Also known as: HFNC

Group intervene with HFNC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Muhammad Irfan Malik

Lahore, Punjab Province, 54500, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 32427171 BACKGROUND

• 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.

  PMID: 32533147 BACKGROUND

• 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.

  PMID: 32448344 BACKGROUND

• 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.

  PMID: 32566624 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Sardar Al-Fareed Zafar

  Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

  STUDY DIRECTOR

Central Study Contacts

Muhammad Irfan Malik, FCPS

CONTACT

03334367220; drmirfanmalik@hotmail.com

Sardar Al-Fareed Zafar, FCPS

CONTACT

03214056891; alfareedivf@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pulmonology / Focal Person COVID-19

Model Details: quasi- experimental

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: September 23, 2020
• Study Start: May 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)