Coronavirus InfectionNCT04424836
HFNC Treatment in COVID-19 Pneumonia
An observational study of Coronavirus Infection and Pneumonia, Viral, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Pneumonia, Viral, Acute Respiratory Failure
- What is being tested?
- high flow nasal cannula device
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: coronavirus disease 2019 patients admitted to the ICU for acute respiratory failure 15 march to 15 may
Who may be able to join
- 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).
Who cannot join
- Patients with primary pulmonary disease, Glasgow Coma scale≤ 12 , respiratory acidosis in the first blood gases(ph≤ 7,2 - pCO2≥50) will exclude.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Research and Training Hospital
Istanbul, 34371
About this study
Official title: the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia
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.
Read the 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.
- Being tested
- high flow nasal cannula device
- Keywords
- high flow nasal cannula (HFNC), conventional oxygen treatment (COT)
- Medical subject headings
- Coronavirus Infections, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannula deviceDevice
device is supplying oxygen with heated and humidified air in a high flow rate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term mortality
the mortality rate of patients
Measured: in 28 days.
icu stay
means the stay day of patients in intensive care unit
Measured: up to 28 days
Secondary outcomes (1)
blood gases
partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg
Measured: at the admission time and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 May 2020
- Primary completion4 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- ayse su cinar, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424836
- Sponsor's protocol ID
- 5569
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32250385Arabi 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.
PubMed 24474051Akerstrom 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.
PubMed 19800091
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04424836
- Acronym / sponsor ID
- 5569
- Keywords
- high flow nasal cannula (HFNC), conventional oxygen treatment (COT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H GROUP | – | Device: high flow nasal cannula devicepatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- coronavirus disease 2019 patients admitted to the ICU for acute respiratory failure 15 march to 15 may
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients with primary pulmonary disease, Glasgow Coma scale≤ 12 , respiratory acidosis in the first blood gases(ph≤ 7,2 - pCO2≥50) will exclude.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal cannula devicedevice is supplying oxygen with heated and humidified air in a high flow rate | Device | H GROUP |
Primary outcome
short term mortality
Time frame: in 28 days.
the mortality rate of patients
icu stay
Time frame: up to 28 days
means the stay day of patients in intensive care unit
1 secondary outcome
blood gases
Time frame: at the admission time and 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Results publication: PubMed 32250385Grasselli 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.
- Results publication: PubMed 24474051Arabi 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.
- Results publication: PubMed 19800091Akerstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayse su cinar study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and Pneumonia, Viral, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short term mortality (time frame: in 28 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424836, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.