HFNC Treatment in COVID-19 Pneumonia

Acute Respiratory Failure Clinical Trial

Official title:

the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424836
• Other study ID #: 5569
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: June 5, 2020

Study information

• Verified date: July 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

Description:

In the first group (group H), the data of patients undergoing HFNC treatment, and in group II (Group K), the data of patients who received COT with a reservoir mask were included.

In HFNC support, the current air temperature is 31-37 degrees, the flow rate is 30-60 lt / min, and the FiO2 value is targeted so that saturation is 93% and above. Initially, continuous treatment was applied intermittently after the partial oxygen pressure / fraction of inspired oxygen(fio2) ratio exceeded 250 and clinical well-being occurred.

In patients in Group K, fingertip saturation was targeted as 93% and above, and a COT was applied with a reservoir mask with a flow rate of 6-15 l / min.

The flow rate was calculated using the formula of FiO2 (%) = 21 + 4 * (liters / min) in patients undergoing COT. Noninvasive mechanical ventilation was applied to patients who could not be provided with adequate clinical and laboratory well-being in both groups (partial oxygen pressure / fraction of inspired oxygen ratio below 150) and invasive mechanical ventilation if this was insufficient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 5, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• We include the patient with acute respiratory failure related coronavirus disease 2019 (diagnosed with polymerase Chain Reaction), older than 18 year and supported by High Flow Nasal cannulae or conventional oxygen treatment(COT).

Exclusion Criteria:

• Patients with primary pulmonary disease, Glasgow Coma scale= 12 , respiratory acidosis in the first blood gases(ph= 7,2 - pCO2=50) will exclude.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Coronavirus Infection
• Coronavirus Infections
• Pneumonia
• Pneumonia, Viral
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome

Intervention

Device:
• high flow nasal cannula device
device is supplying oxygen with heated and humidified air in a high flow rate

Locations

Country	Name	City	State
Turkey	Sisli Etfal Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Akerström S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 O — View Citation

Arabi YM, Arifi AA, Balkhy HH, Najm H, Aldawood AS, Ghabashi A, Hawa H, Alothman A, Khaldi A, Al Raiy B. Clinical course and outcomes of critically ill patients with Middle East respiratory syndrome coronavirus infection. Ann Intern Med. 2014 Mar 18;160(6 — View Citation

Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lomb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short term mortality	the mortality rate of patients	in 28 days.
Primary	icu stay	means the stay day of patients in intensive care unit	up to 28 days
Secondary	blood gases	partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg	at the admission time and 24th hour