High-Flow Nasal Cannula in Severe COVID-19 With Acute Hypoxemic Respiratory Failure. (HiFlo-COVID)
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|ClinicalTrials.gov Identifier: NCT04609462|
Recruitment Status : Completed
First Posted : October 30, 2020
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Acute Hypoxemic Respiratory Failure||Procedure: Conventional oxygen therapy Procedure: High flow nasal cannula||Not Applicable|
Acute hypoxemic respiratory failure is a condition in which rapid-onset impairment in gas exchange between the lungs and the blood, lead to hypoxemia with or without hypercapnia. Usual management of this condition relies on oxygen supplementation throughout different respiratory support modalities (i.e., low flow oxygen devices, high-flow nasal cannulas, mechanical ventilation, ECMO, etc.) aiming to restore gas exchange and to support respiratory effort. In most cases, initial management of acute hypoxemic respiratory failure might be provided through low-flow oxygen systems, but more severe cases will require more advanced life-supporting strategies.
Respiratory compromise by SARS-CoV-2 infection widely varies between subjects. Thus, respiratory system elastance, intrapulmonary shunt, pulmonary perfusion/ventilation inequalities and lung weight can range between almost normal up to very high values. Consequently, modalities to provide initial support in acute severe hypoxemic respiratory failure in SARS-CoV-2 infection should not be limited to immediate invasive mechanical ventilation support as such respiratory support modalities should be adapted to individual requirements.
Unfortunately, similar values of initial PaO2/FiO2 ratios (especially when PaO2/FiO2 ratio is < 200) are not clearly related with more or less severe lung affectation, high or low respiratory system elastance patterns, high or low adaptive hypoxic vasoconstriction, and far beyond clinical signs, there are no widely available methods able to rapidly decide which patients would be more benefit from a relative "conservative" management or on the contrary, which patient would benefit from immediate invasive respiratory support.
Use of high-flow nasal cannulas (HFNC) in acute hypoxemic respiratory failure from different etiologies has rapidly increased during the last years. Certainly, randomized controlled trials suggest that HFNC might prevent intubation and the need for invasive mechanical ventilation in patients with moderate and severe hypoxemia. Nevertheless, impact of HFNC on mortality rates and other important clinical outcomes in this condition remains controversial.
Initial observational reports of patients with severe SARS-CoV-2 infection subjected to invasive mechanical ventilation showed a consistent and very high mortality. Indeed, some experts claimed for using such non-invasive respiratory support devices in patients with moderate or even high pulmonary shunt values arguing about possible harm induced by mechanical ventilation especially in patients with a relative normal respiratory system elastance. Nevertheless, others recommended against HFNC use because safety concerns for health care workers, which clearly limited its use at the initial phases of the pandemic. Thus, the impact and safety of using HFNC at very early stages of acute hypoxemic respiratory failure induced by severe SARS-CoV-2 infection remain to be elucidated. This is how the HiFlo-COVID trial propose to assess the impact HFNC vs. conventional oxygen therapy on the need for intubation / invasive mechanical ventilation support and the clinical status (at days-14 and -28) as assessed by a modified 7-point ordinal scale in patients with moderate / severe hypoxemic respiratory failure secondary to SARS-CoV-2 infection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase II, multicenter, randomized, open-label, controlled study of the use of high flow nasal cannula respiratory support vs. conventional oxygen therapy in patients with moderate/severe hypoxemic respiratory failure secondary to SARS-CoV-2 infection.|
|Masking:||None (Open Label)|
|Official Title:||A Trial of High-Flow Nasal Cannula vs. Conventional Oxygen Therapy in Patients With SARS-CoV-2-Related Acute Respiratory Failure: the HiFlo-COVID Trial.|
|Actual Study Start Date :||August 11, 2020|
|Actual Primary Completion Date :||January 13, 2021|
|Actual Study Completion Date :||February 10, 2021|
Active Comparator: Conventional oxygen therapy (COT) group
Oxygen therapy will be delivered by conventional nasal cannula / prongs, venturi mask, or mask with reservoir, with flows between 3 and 15 liters / minute, to ensure SpO2 ≥ 92%.
Procedure: Conventional oxygen therapy
Oxygen therapy by conventional nasal cannula / prongs, venturi mask, or mask with reservoir
Experimental: High-flow nasal cannula (HFNC) group
Breathing support with High-Flow oxygen therapy, flow will be initiated between 50 and 60 liters / minute. FiO2 60% to 100% with the objective of reaching SpO2 ≥ 92%. Adequate wetting of the system should be ensured according to the recommendations of the HFNC device manufacturer. FiO2 may be decreased gradually according to the patient's individual condition, trying to maintain SpO2 ≥ 92%.
Procedure: High flow nasal cannula
Breathing support with High-flow nasal cannula
- Intubation rate [ Time Frame: 28 days ]Need for intubation / support with invasive mechanical ventilation.
- Clinical recovery [ Time Frame: 28 days ]
Time to improvement of clinical status according to the 7-point ordinal scale.
Modified 7-point ordinal scale:
- An ordinal scale of 7 points where 1= Ambulatory/no limitation of activities and 7= Death. Low scores denote a better outcome and high scores denote a worse outcome.
- Time to reduction in scale score will be measured (daily scale scoring).
- Proportion of patients with requirement of early mechanical ventilation. [ Time Frame: 7 and 14 days ]
Whether or not each patient required mechanical ventilation during the first 7 and 14 days after randomization will be assessed.
Proportion of patients with early mechanical ventilation will be calculated for each group.
- Mechanical ventilation-free days [ Time Frame: 28 days ]Days off from mechanical ventilation
- Renal replacement therapy-free days [ Time Frame: 28 days ]Days off from renal replacement therapy
- Length of ICU stay [ Time Frame: 28 days ]Duration of stay in ICU
- Length of hospital stay [ Time Frame: 28 days ]Duration of hospital stay
- All-cause day-28 mortality [ Time Frame: 28 days ]Hospital mortality
- Proportion of serious adverse events [ Time Frame: 28 days ]Proportion of patients with serious adverse events during hospital stay
- Proportion of bacterial - fungal infections [ Time Frame: 28 days ]Proportion of bacterial - fungal infections during hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609462
|Fundacion Valle del Lili|
|Cali, Valle Del Cauca, Colombia, 76032|
|Principal Investigator:||Gustavo A. Ospina Tascón, MDPhD||Fundacion Clinica Valle del Lili|