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

• Sponsor: Pomeranian Medical University Szczecin (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05197686
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection; ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2; Oxygen Deficiency	Device: Oxygen theraphy with high flow nasal cannule; Device: Oxygen theraphy with mask with reservoir	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Groups are designed by web randomizer.
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Jan 18, 2022
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HFNC	Device: Oxygen theraphy with high flow nasal cannule; Oxygen theraphy with high flow nasal cannule
Active Comparator: COT	Device: Oxygen theraphy with mask with reservoir; Oxygen theraphy with mask with reservoir

Outcome Measures

Primary Outcome Measures

1. Lower mortality in HFNC group [6 months]

2. Lower percent of intubation in HFNC group [6 months]

3. Shorter time of hospitalization in HFNC group [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxygen Therapy Sector of Temporary Hospital	Szczecin	Zachodniopomorskie	Poland	71-004

Sponsors and Collaborators

• Pomeranian Medical University Szczecin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• Rorat M, Szymański 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.
• Sayan İ, Altınay M, Çınar AS, Türk HŞ, Peker N, Şahin K, Coşkun 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.
• 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.
• 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.

• Responsible Party: Pomeranian Medical University Szczecin
• ClinicalTrials.gov Identifier: NCT05197686
• Other Study ID Numbers: KB-0012/58/2021
• First Posted: Jan 19, 2022
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pomeranian Medical University Szczecin: SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.
• Additional relevant MeSH terms: Pneumonia; Coronavirus Infections; Severe Acute Respiratory Syndrome; COVID-19; Hypoxia

Study Results

No Results Posted as of Jan 19, 2022