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High Flow Nasal Cannula HFNC In Covid-19 Patients (HFNC19LGH)

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High flow nasal cannula HFNC
Sponsored by
Lahore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring COVID-19, High flow nasal cannula HFNC, Clinical outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muhammad Irfan MalikRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group intervene with HFNC

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of intervention
Length of HFNC therapy to COVID-19 patients
Duration of hospitalization
Number of days of hospital admission either in ICU or HDUs till date of discharge
Supplemental Oxygen Requirement from Baseline
Duration of increased supplemental oxygen requirement from baseline
Radiological outcome
Follow up radiological response HR-CT.

Full Information

First Posted
July 13, 2020
Last Updated
December 4, 2020
Sponsor
Lahore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04560257
Brief Title
High Flow Nasal Cannula HFNC In Covid-19 Patients
Acronym
HFNC19LGH
Official Title
Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
Keywords
COVID-19, High flow nasal cannula HFNC, Clinical outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi- experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group intervene with HFNC
Arm Type
Experimental
Arm Description
Review effect of HFNC as clinical trial among hospitalized patients with COVID-19 infection.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula HFNC
Other Intervention Name(s)
HFNC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response of HFNC
Description
The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Duration of intervention
Description
Length of HFNC therapy to COVID-19 patients
Time Frame
15 days
Title
Duration of hospitalization
Description
Number of days of hospital admission either in ICU or HDUs till date of discharge
Time Frame
15 days
Title
Supplemental Oxygen Requirement from Baseline
Description
Duration of increased supplemental oxygen requirement from baseline
Time Frame
15 days
Title
Radiological outcome
Description
Follow up radiological response HR-CT.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Irfan Malik, FCPS
Phone
03334367220
Email
drmirfanmalik@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sardar Al-Fareed Zafar, FCPS
Phone
03214056891
Email
alfareedivf@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sardar Al-Fareed Zafar
Organizational Affiliation
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Official's Role
Study Director
Facility Information:
Facility Name
Muhammad Irfan Malik
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54500
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Irfan Malik, FCPS
Phone
03334367220
Email
drmirfanmalik@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sardar Al-Fareed Zafar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32427171
Citation
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.
Results Reference
background
PubMed Identifier
32533147
Citation
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.
Results Reference
background
PubMed Identifier
32448344
Citation
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.
Results Reference
background
PubMed Identifier
32566624
Citation
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.
Results Reference
background

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High Flow Nasal Cannula HFNC In Covid-19 Patients

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