COVID-19
Conditions
Interventions
HFNC treatment on the appointed general wards, the emergency department or on the ICU. Patients will be treated according to the current local guidelines of the hospital, within their standard of care
Sponsors
No sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The population included will be hospitalized patients with confirmed COVID-19, = 18 years old with isolated severe hypoxic respiratory failure defined as: SpO2 30/min despite treatment with at least 6 L/min oxygen therapy on nasal cannula. These patients may be included at the pulmonary departments delivering COVID-19 care, intensive care units or directly on the Emergency department. SARS-CoV-2 negative patients (nasopharyngeal PCR) will be excluded for this analysis, retrospectively. Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria: ? Age = 18 years ? Admitted to the hospital ? Suspect of COVID-19 or nasopharyngeal swab PCR confirmed COVID-19 ? SpO2 30/min despite at least 6L O2/min on nasal cannula.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: ? Reasons for direct intubation, as per local standard of clinical care. ? Patient does not accept treatment with HFNC ? Anatomic abnormalities (recent surgery of the face, nose, or airway) that preclude an appropriate-fitting nasal cannula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is HFNC failure. HFNC failure is defined as: ? Patients without a DNI policy: Intubation. or ? Patients with DNI policy: Persistent hypoxemia, defined as SpO2 < 90% despite a maximum FiO2 (>90%) and flow (>50L/min) and/or death because of terminal respiratory failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of HFNC > Proportion of non-ICU admitted HFNC patients requiring ICU admission > Proportion of HFNC patients requiring NIV (CPAP or BiPAP) > Duration of HFNC therapy (ward vs ICU) To identify risk factors associated with treatment failure of HFNC (baseline risk factors or time-dependent/treatment-related risk factors) To determine the long-term consequences of the use of HFNC therapy on physical activity level, persisting symptoms and health-related quality of life in severe COVID-19 patients who were treated with HFNC. Tertiary outcome* To determine the evolution of the ROX index in severe hypoxic COVID-19 patients during HFNC treatment. To compare primary and secondary endpoints between subgroups of patients such as: a. Early HFNC start (defined as: maximum 6L O2/min) vs. late (defined as: more than 6L O2/min). b. Start HFNC with low or high ROX index c. Start HFNC on ward vs. ICU d. Start HFNC with a flow of 40L/min vs. flow > 40L/min e. Centers with HFNC only in ICU vs. Center with HFNC in ward and ICU Longer duration of HFNC therapy is associated with persistent long-term symptoms and poorer long-term outcomes on quality of life and physical performance . | — |
Contacts
Public ContactYasemin Türk
Franciscus Gasthuis & Vlietland
Outcome results
None listed