Back to resultsEarly-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.
Primary Purpose
Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Oxygen theraphy with high flow nasal cannule
Oxygen theraphy with mask with reservoir
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection focused on measuring SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Sites / Locations
- Oxygen Therapy Sector of Temporary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HFNC
COT
Arm Description
Outcomes
Primary Outcome Measures
Lower mortality in HFNC group
Lower percent of intubation in HFNC group
Shorter time of hospitalization in HFNC group
Secondary Outcome Measures
Full Information
NCT ID
NCT05197686
First Posted
January 18, 2022
Last Updated
January 18, 2022
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT05197686
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 18, 2022 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pomeranian Medical University Szczecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Groups are designed by web randomizer.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC
Arm Type
Experimental
Arm Title
COT
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Oxygen theraphy with high flow nasal cannule
Intervention Description
Oxygen theraphy with high flow nasal cannule
Intervention Type
Device
Intervention Name(s)
Oxygen theraphy with mask with reservoir
Intervention Description
Oxygen theraphy with mask with reservoir
Primary Outcome Measure Information:
Title
Lower mortality in HFNC group
Time Frame
6 months
Title
Lower percent of intubation in HFNC group
Time Frame
6 months
Title
Shorter time of hospitalization in HFNC group
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wojciech Witkiewicz
Phone
+48509082762
Email
witkiewiczwojciech@gmail.com
Facility Information:
Facility Name
Oxygen Therapy Sector of Temporary Hospital
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-004
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33547065
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.
Results Reference
background
PubMed Identifier
33621840
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.
Results Reference
background
PubMed Identifier
32448330
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.
Results Reference
background
PubMed Identifier
32703883
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.
Results Reference
background
PubMed Identifier
34682874
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.
Results Reference
background
Learn more about this trial
Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.
We'll reach out to this number within 24 hrs