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HFNC Treatment in COVID-19 Pneumonia

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

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.

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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

Resource links provided by the National Library of Medicine


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.



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424836


Locations
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Turkey
Sisli Etfal Research and Training Hospital
Istanbul, Turkey, 34371
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
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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

Publications of Results:
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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    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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