SARS-CoV InfectionHFNC19LGHNCT04560257
High Flow Nasal Cannula HFNC In Covid-19 Patients
A study testing High flow nasal cannula HFNC in people with SARS-CoV Infection and SARS (Severe Acute Respiratory Syndrome), run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- High flow nasal cannula HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Pneumothorax
- Nasal blockade
- Unable to tolerate high flow oxygen
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Irfan Malik
Lahore, Punjab Province, 54500
Muhammad Irfan Malik, FCPS, 03334367220, drmirfanmalik@hotmail.com
Sardar Al-Fareed Zafar
About this study
Official title: 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.
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.
- Being tested
- High flow nasal cannula HFNC
- Keywords
- COVID-19, High flow nasal cannula HFNC, Clinical outcome
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula HFNCDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Group intervene with HFNC | Experimental | Review effect of HFNC as clinical trial among hospitalized patients with COVID-19 infection. Receives: Device: High flow nasal cannula HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response of HFNC
The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)
Measured: 10 days
Secondary outcomes (4)
Duration of intervention
Length of HFNC therapy to COVID-19 patients
Measured: 15 days
Duration of hospitalization
Number of days of hospital admission either in ICU or HDUs till date of discharge
Measured: 15 days
Supplemental Oxygen Requirement from Baseline
Duration of increased supplemental oxygen requirement from baseline
Measured: 15 days
Radiological outcome
Follow up radiological response HR-CT.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 May 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi- experimental
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. M.Irfan Malik, Lahore General Hospital
- Investigators
- Sardar Al-Fareed Zafar, Study director, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560257
- Sponsor's protocol ID
- LGH004
- Acronym
- HFNC19LGH
- Status last verified
- Dec 2020
- First submitted
- 13 Jul 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32427171Richards 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 32533147Pinkham 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 32448344Tu 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome
- ClinicalTrials.gov ID
- NCT04560257
- Acronym / sponsor ID
- HFNC19LGH / LGH004
- Keywords
- COVID-19, High flow nasal cannula HFNC, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi- experimental
| Arm | Type | Receives |
|---|---|---|
| Group intervene with HFNC | Experimental | Device: High flow nasal cannula HFNCReview effect of HFNC as clinical trial among hospitalized patients with COVID-19 infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannula HFNCAlso: HFNCHigh 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. | Device | Group intervene with HFNC |
Primary outcome
Clinical response of HFNC
Time frame: 10 days
The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)
4 secondary outcomes
Duration of intervention
Time frame: 15 days
Duration of hospitalization
Time frame: 15 days
Supplemental Oxygen Requirement from Baseline
Time frame: 15 days
Radiological outcome
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 32427171Whittle 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.
- Background: PubMed 32533147Richards 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.
- Background: PubMed 32448344Pinkham 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.
- Background: PubMed 32566624Tu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sardar Al-Fareed Zafar study director
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula HFNC in people with SARS-CoV Infection and SARS (Severe Acute Respiratory Syndrome), run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Irfan Malik, FCPS (03334367220, drmirfanmalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response of HFNC (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560257, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.