HFNC19LGH: High Flow Nasal Cannula HFNC In Covid-19 Patients

Sponsor
Lahore General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04560257
Collaborator
(none)
30
1
1
8
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High flow nasal cannula HFNC
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
quasi- experimentalquasi- experimental
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical response of HFNC [10 days]

      The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)

    Secondary Outcome Measures

    1. Duration of intervention [15 days]

      Length of HFNC therapy to COVID-19 patients

    2. Duration of hospitalization [15 days]

      Number of days of hospital admission either in ICU or HDUs till date of discharge

    3. Supplemental Oxygen Requirement from Baseline [15 days]

      Duration of increased supplemental oxygen requirement from baseline

    4. Radiological outcome [15 days]

      Follow up radiological response HR-CT.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Muhammad Irfan Malik Lahore Punjab Pakistan 54500

    Sponsors and Collaborators

    • Lahore General Hospital

    Investigators

    • Study Director: Sardar Al-Fareed Zafar, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
    ClinicalTrials.gov Identifier:
    NCT04560257
    Other Study ID Numbers:
    • LGH004
    First Posted:
    Sep 23, 2020
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 8, 2020