High Flow Nasal Cannula HFNC In Covid-19 Patients

NCT ID: NCT04560257

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SARS-CoV Infection SARS (Severe Acute Respiratory Syndrome)

Keywords

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COVID-19 High flow nasal cannula HFNC Clinical outcome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

quasi- experimental
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group intervene with HFNC

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Group Type EXPERIMENTAL

High flow nasal cannula HFNC

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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HFNC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lahore General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. M.Irfan Malik

Associate Professor of Pulmonology / Focal Person COVID-19

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sardar Al-Fareed Zafar

Role: STUDY_DIRECTOR

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

Locations

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Muhammad Irfan Malik

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Irfan Malik, FCPS

Role: CONTACT

Phone: 03334367220

Email: [email protected]

Sardar Al-Fareed Zafar, FCPS

Role: CONTACT

Phone: 03214056891

Email: [email protected]

Facility Contacts

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Muhammad Irfan Malik, FCPS

Role: primary

Sardar Al-Fareed Zafar

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32427171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32533147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32448344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32566624 (View on PubMed)

Other Identifiers

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LGH004

Identifier Type: -

Identifier Source: org_study_id