HFNC Treatment in COVID-19 Pneumonia

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04424836
Collaborator
(none)
43
1
21
62.3

Study Details

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 Phase
  • 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 :
Jun 4, 2020
Actual Study Completion Date :
Jun 5, 2020

Arms and Interventions

Arm 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 [in 28 days.]

    the mortality rate of patients

  2. icu stay [up to 28 days]

    means the stay day of patients in intensive care unit

Secondary Outcome Measures

  1. blood gases [at the admission time and 24th hour]

    partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 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)

More Information

Publications

None provided.
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:
Jun 11, 2020
Last Update Posted:
Jul 16, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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, specialist medical doctor, Sisli Hamidiye Etfal Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2020