Clinical trial NCT04560257: High Flow Nasal Cannula HFNC In Covid-19 Patients
Official title: Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV Infection
SARS (Severe Acute Respiratory Syndrome)
Keywords: COVID-19
High flow nasal cannula HFNC
Clinical outcome
Lead sponsor: Lahore General Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quasi- experimental
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical response of HFNC
timeFrame: 10 days
Secondary outcomes:
measure: Duration of intervention
timeFrame: 15 days
measure: Duration of hospitalization
timeFrame: 15 days
measure: Supplemental Oxygen Requirement from Baseline
timeFrame: 15 days
measure: Radiological outcome
timeFrame: 15 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Muhammad Irfan Malik
state: Punjab
Study officials:
affiliation: Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
name: Sardar Al-Fareed Zafar
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.