Corona Virus InfectionNCT05197686
Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.
A study testing Oxygen theraphy with high flow nasal cannule and Oxygen theraphy with mask with reservoir in people with Corona Virus Infection and ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency
- What is being tested?
- Oxygen theraphy with high flow nasal cannule and Oxygen theraphy with mask with reservoir
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test [allowed in Poland, with sensitivity ≥90 and specificity ≥97]);
- Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin;
- Pneumonia during SARS-CoV2 infection;
- ARDS (PaO 2 / FiO 2 ratio ≤300);
- Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 < 92%;
- TNo current indications for treatment in the ICU;
- Permisson of the patient.
Who cannot join
- Probable lack of cooperation with patient;
- Severe Disease disease, eg generalized neoplastic disease;
- Concomitant pulmonary diseases (eg, fibrosis lungs);
- Respiratory acidosis - pH <7.3 with pCO2> 50 mmHg;
- Disturbances of consciousness - GCS < 12;
Trial locations and contacts
1 site in 1 country.
Poland1 site
Oxygen Therapy Sector of Temporary Hospital
Szczecin, West Pomeranian Voivodeship, 71-004
About this study
Official title: Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia: Prognosis and Impact on the Respiratory and Cardiovascular Systems.
The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. However, there have been reports in the literature that early initiation of high-flow oxygen therapy with a nasal cannula is associated with better prognosis. The study we perform is intended to provide reliable evidence for confirmation this hypothesis.
- Conditions
- Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency
- Being tested
- Oxygen theraphy with high flow nasal cannule, Oxygen theraphy with mask with reservoir
- Keywords
- SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.
- Medical subject headings
- Coronavirus Infections, Hypoxia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen theraphy with high flow nasal cannuleDevice
Oxygen theraphy with high flow nasal cannule
Oxygen theraphy with mask with reservoirDevice
Oxygen theraphy with mask with reservoir
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Experimental | Not described Receives: Device: Oxygen theraphy with high flow nasal cannule |
| COT | Active comparator | Not described Receives: Device: Oxygen theraphy with mask with reservoir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower mortality in HFNC group
Measured: 6 months
Lower percent of intubation in HFNC group
Measured: 6 months
Shorter time of hospitalization in HFNC group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start18 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corona Virus 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197686
- Sponsor's protocol ID
- KB-0012/58/2021
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baker KF, Hanrath AT, Schim van der Loeff I, Kay LJ, Back J, Duncan CJ. National Early Warning Score 2 (NEWS2) to identify inpatient COVID-19 deterioration: a retrospective analysis. Clin Med (Lond). 2021 Mar;21(2):84-89. doi: 10.7861/clinmed.2020-0688. Epub 2021 Feb 5.
PubMed 33547065Sayan I, Altinay M, Cinar AS, Turk HS, Peker N, Sahin K, Coskun N, Demir GD. Impact of HFNC application on mortality and intensive care length of stay in acute respiratory failure secondary to COVID-19 pneumonia. Heart Lung. 2021 May-Jun;50(3):425-429. doi: 10.1016/j.hrtlng.2021.02.009. Epub 2021 Feb 10.
PubMed 33621840Xu Q, Wang T, Qin X, Jie Y, Zha L, Lu W. Early awake prone position combined with high-flow nasal oxygen therapy in severe COVID-19: a case series. Crit Care. 2020 May 24;24(1):250. doi: 10.1186/s13054-020-02991-7. No abstract available.
PubMed 32448330Vianello A, Arcaro G, Molena B, Turato C, Sukthi A, Guarnieri G, Lugato F, Senna G, Navalesi P. High-flow nasal cannula oxygen therapy to treat patients with hypoxemic acute respiratory failure consequent to SARS-CoV-2 infection. Thorax. 2020 Nov;75(11):998-1000. doi: 10.1136/thoraxjnl-2020-214993. Epub 2020 Jul 23.
PubMed 32703883Rorat M, Szymanski W, Jurek T, Karczewski M, Zelig J, Simon K. When Conventional Oxygen Therapy Fails-The Effectiveness of High-Flow Nasal Oxygen Therapy in Patients with Respiratory Failure in the Course of COVID-19. J Clin Med. 2021 Oct 16;10(20):4751. doi: 10.3390/jcm10204751.
PubMed 34682874
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia: Prognosis and Impact on the Respiratory and Cardiovascular Systems.
- ClinicalTrials.gov ID
- NCT05197686
- Acronym / sponsor ID
- KB-0012/58/2021
- Conditions
- Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency
- Keywords
- SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 18 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jan 2022 (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.
The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. However, there have been reports in the literature that early initiation of high-flow oxygen therapy with a nasal cannula is associated with better prognosis. The study we perform is intended to provide reliable evidence for confirmation this hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | Experimental | Device: Oxygen theraphy with high flow nasal cannule |
| COT | Active comparator | Device: Oxygen theraphy with mask with reservoir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test [allowed in Poland, with sensitivity ≥90 and specificity ≥97]);
- Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin;
- Pneumonia during SARS-CoV2 infection;
- ARDS (PaO 2 / FiO 2 ratio ≤300);
- Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 < 92%;
Key exclusion criteria (5 listed)
- Probable lack of cooperation with patient;
- Severe Disease disease, eg generalized neoplastic disease;
- Concomitant pulmonary diseases (eg, fibrosis lungs);
- Respiratory acidosis - pH <7.3 with pCO2> 50 mmHg;
- Disturbances of consciousness - GCS < 12;
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 |
|---|---|---|
| Oxygen theraphy with high flow nasal cannuleOxygen theraphy with high flow nasal cannule | Device | HFNC |
| Oxygen theraphy with mask with reservoirOxygen theraphy with mask with reservoir | Device | COT |
Primary outcome
Lower mortality in HFNC group
Time frame: 6 months
Lower percent of intubation in HFNC group
Time frame: 6 months
Shorter time of hospitalization in HFNC group
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 33547065Baker KF, Hanrath AT, Schim van der Loeff I, Kay LJ, Back J, Duncan CJ. National Early Warning Score 2 (NEWS2) to identify inpatient COVID-19 deterioration: a retrospective analysis. Clin Med (Lond). 2021 Mar;21(2):84-89. doi: 10.7861/clinmed.2020-0688. Epub 2021 Feb 5.
- Background: PubMed 33621840Sayan I, Altinay M, Cinar AS, Turk HS, Peker N, Sahin K, Coskun N, Demir GD. Impact of HFNC application on mortality and intensive care length of stay in acute respiratory failure secondary to COVID-19 pneumonia. Heart Lung. 2021 May-Jun;50(3):425-429. doi: 10.1016/j.hrtlng.2021.02.009. Epub 2021 Feb 10.
- Background: PubMed 32448330Xu Q, Wang T, Qin X, Jie Y, Zha L, Lu W. Early awake prone position combined with high-flow nasal oxygen therapy in severe COVID-19: a case series. Crit Care. 2020 May 24;24(1):250. doi: 10.1186/s13054-020-02991-7. No abstract available.
- Background: PubMed 32703883Vianello A, Arcaro G, Molena B, Turato C, Sukthi A, Guarnieri G, Lugato F, Senna G, Navalesi P. High-flow nasal cannula oxygen therapy to treat patients with hypoxemic acute respiratory failure consequent to SARS-CoV-2 infection. Thorax. 2020 Nov;75(11):998-1000. doi: 10.1136/thoraxjnl-2020-214993. Epub 2020 Jul 23.
- Background: PubMed 34682874Rorat M, Szymanski W, Jurek T, Karczewski M, Zelig J, Simon K. When Conventional Oxygen Therapy Fails-The Effectiveness of High-Flow Nasal Oxygen Therapy in Patients with Respiratory Failure in the Course of COVID-19. J Clin Med. 2021 Oct 16;10(20):4751. doi: 10.3390/jcm10204751.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen theraphy with high flow nasal cannule and Oxygen theraphy with mask with reservoir in people with Corona Virus Infection and ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Witkiewicz (+48509082762, witkiewiczwojciech@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower mortality in HFNC group (time frame: 6 months). The study lists 3 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 NCT05197686, which also lists 5 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 19 Jan 2022.