NCT04424836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

20 days

First QC Date

June 7, 2020

Last Update Submit

July 15, 2020

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • short term mortality

    the mortality rate of patients

    in 28 days.

  • icu stay

    means the stay day of patients in intensive care unit

    up to 28 days

Secondary Outcomes (1)

  • blood gases

    at the admission time and 24th hour

Study Arms (2)

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

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.

Interventions

device is supplying oxygen with heated and humidified air in a high flow rate

H GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Research and Training Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • Akerstrom 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.

MeSH Terms

Conditions

Coronavirus InfectionsPneumonia, Viral

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • ayse su cinar

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

May 15, 2020

Primary Completion

June 4, 2020

Study Completion

June 5, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations