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Status unknownNCT04560257HFNC19LGHUpdated Dec 8, 2020

High Flow Nasal Cannula HFNC In Covid-19 Patients

An interventional study of High flow nasal cannula HFNC in SARS-CoV Infection and SARS (Severe Acute Respiratory Syndrome), sponsored by Lahore General Hospital. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Lahore General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • COVID-19
  • High flow nasal cannula HFNC
  • Clinical outcome
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Lahore General Hospital is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceHigh 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.

    Also known as: HFNC

06

What researchers measure

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)

    Time frame: 10 days

Secondary outcomes

  1. Duration of intervention

    Length of HFNC therapy to COVID-19 patients

    Time frame: 15 days

  2. Duration of hospitalization

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

    Time frame: 15 days

  3. Supplemental Oxygen Requirement from Baseline

    Duration of increased supplemental oxygen requirement from baseline

    Time frame: 15 days

  4. Radiological outcome

    Follow up radiological response HR-CT.

    Time frame: 15 days

07

Study locations

1 of 1 sites recruiting
  • Muhammad Irfan Malik
    Lahore, Punjab 54500, Pakistan
    Recruiting
08

References and documents

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. PubMed 32427171 ↗
  • 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. PubMed 32533147 ↗
  • 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. PubMed 32448344 ↗
  • 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. PubMed 32566624 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04560257
Lead sponsor
Lahore General Hospital
Responsible party
Dr. M.Irfan Malik (Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital) — Principal investigator
First posted
Sep 23, 2020
Start date
May 1, 2020
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Dec 8, 2020

Study contacts

Muhammad Irfan Malik, FCPS
Contact
drmirfanmalik@hotmail.com
03334367220
Sardar Al-Fareed Zafar, FCPS
Contact
alfareedivf@hotmail.com
03214056891
Sardar Al-Fareed Zafar
study director · Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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