Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.

Corona Virus Infection Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05197686
• Other study ID #: KB-0012/58/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Pomeranian Medical University Szczecin
• Contact: Wojciech Witkiewicz
• Phone: +48509082762
• Email: witkiewiczwojciech[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Hypoxia
• Oxygen Deficiency
• Pneumonia
• Severe Acute Respiratory Syndrome

Intervention

Device:
• Oxygen theraphy with high flow nasal cannule
Oxygen theraphy with high flow nasal cannule
• Oxygen theraphy with mask with reservoir
Oxygen theraphy with mask with reservoir

Locations

Country	Name	City	State
Poland	Oxygen Therapy Sector of Temporary Hospital	Szczecin	Zachodniopomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View 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). pii: 4751. doi: 10.3390/jcm10204751. — View Citation

Sayan I, Altinay M, Çinar AS, Türk 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower mortality in HFNC group		6 months
Primary	Lower percent of intubation in HFNC group		6 months
Primary	Shorter time of hospitalization in HFNC group		6 months