Clinical trial NCT05197686: Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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.
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test \[allowed in Poland, with sensitivity ≥90 and specificity ≥97\]);
2. Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin;
3. Pneumonia during SARS-CoV2 infection;
4. ARDS (PaO 2 / FiO 2 ratio ≤300);
5. Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 \< 92%;
6. TNo current indications for treatment in the ICU;
7. Permisson of the patient.

Exclusion Criteria:

1. Probable lack of cooperation with patient;
2. Severe Disease disease, eg generalized neoplastic disease;
3. Concomitant pulmonary diseases (eg, fibrosis lungs);
4. Respiratory acidosis - pH \<7.3 with pCO2\> 50 mmHg;
5. Disturbances of consciousness - GCS \< 12;

Primary outcomes:
measure: Lower mortality in HFNC group
timeFrame: 6 months
measure: Lower percent of intubation in HFNC group
timeFrame: 6 months
measure: Shorter time of hospitalization in HFNC group
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Oxygen Therapy Sector of Temporary Hospital
state: Zachodniopomorskie
Study officials:
References:
citation: 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.
citation: Sayan 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.
citation: Xu 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.
citation: Vianello 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.
citation: Rorat 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.