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

NCT05197686 | Unknown

• 1 other identifier: KB-0012/58/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (3)

• Lower mortality in HFNC group

  6 months

• Lower percent of intubation in HFNC group

  6 months

• Shorter time of hospitalization in HFNC group

  6 months

Study Arms (2)

HFNC

EXPERIMENTAL

Device: Oxygen theraphy with high flow nasal cannule

COT

ACTIVE COMPARATOR

Device: Oxygen theraphy with mask with reservoir

Interventions

Oxygen theraphy with high flow nasal cannule DEVICE

Oxygen theraphy with high flow nasal cannule

HFNC

Oxygen theraphy with mask with reservoir DEVICE

Oxygen theraphy with mask with reservoir

COT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Oxygen Therapy Sector of Temporary Hospital

Szczecin, West Pomeranian Voivodeship, 71-004, Poland

Location

Related 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.

  PMID: 33547065 BACKGROUND

• 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.

  PMID: 33621840 BACKGROUND

• 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.

  PMID: 32448330 BACKGROUND

• 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.

  PMID: 32703883 BACKGROUND

• 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.

  PMID: 34682874 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Hypoxia; COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Wojciech Witkiewicz

CONTACT

+48509082762; witkiewiczwojciech@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Groups are designed by web randomizer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 19, 2022
• Study Start: January 18, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

PL (1)