HFNC Treatment in COVID-19 Pneumonia

• ClinicalTrials.gov Identifier: NCT04424836
• Recruitment Status: Completed
• First Posted: June 11, 2020
• Last Update Posted: July 16, 2020
• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Information provided by (Responsible Party): Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Coronavirus Infection; Pneumonia, Viral; Acute Respiratory Failure	Device: high flow nasal cannula device

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia
• Actual Study Start Date: May 15, 2020
• Actual Primary Completion Date: June 4, 2020
• Actual Study Completion Date: June 5, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
H GROUP; patients get the oxygen supply with high flow nasal cannula . In group H, HFNC device settings the initial flow rate was 30 L/min and could be increased to 60. The Fio2 was adjusted to maintain oxygen saturation as indicated by a pulse oximetry reading of grater than or equal to %90.	Device: high flow nasal cannula device; device is supplying oxygen with heated and humidified air in a high flow rate
C GROUP; patients get the oxygen supply with conventional methods. In group C 6-15 L/min oxygen delivered to patients by conventional methods and targeted to maintain the oxygen saturation %90 or over.

Outcome Measures

Primary Outcome Measures :

1. short term mortality [ Time Frame: in 28 days. ]
   the mortality rate of patients
2. icu stay [ Time Frame: up to 28 days ]
   means the stay day of patients in intensive care unit

Secondary Outcome Measures :

1. blood gases [ Time Frame: at the admission time and 24th hour ]
   partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

coronavirus disease 2019 patients admitted to the ICU for acute respiratory failure 15 march to 15 may

Criteria

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.

Contacts and Locations

Locations

Turkey

Sisli Etfal Research and Training Hospital

Istanbul, Turkey, 34371

Sponsors and Collaborators

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

• Study Chair: ayse su cinar

  Study Documents (Full-Text)

Documents provided by Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital:

Study Protocol  [PDF] June 6, 2020

Statistical Analysis Plan  [PDF] June 6, 2020

More Information

Publications of Results:

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 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

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):389-97. doi: 10.7326/M13-2486.

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 Oct 1.

• Responsible Party: Mustafa Altınay, specialist medical doctor, Sisli Hamidiye Etfal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04424836
• Other Study ID Numbers: 5569
• First Posted: June 11, 2020
• Last Update Posted: July 16, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital:

high flow nasal cannula (HFNC); conventional oxygen treatment (COT)

Additional relevant MeSH terms:

Coronavirus Infections; Severe Acute Respiratory Syndrome; Pneumonia, Viral; Pneumonia; Respiratory Insufficiency; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiration Disorders