HFNT vs. COT in COVID-19
- Conditions
- Covid19Acute Respiratory Failure
- Interventions
- Device: Conventional Oxygen TherapyDevice: High Flow Nasal Therapy
- Registration Number
- NCT04655638
- Lead Sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Brief Summary
The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.
- Detailed Description
The interventions will be delivered in any hospital ward caring for COVID-19 patients.
The interventions under investigation will be high flow nasal therapy in comparison with conventional oxygen therapy.
HFNT will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. A feeding tube or a nasogastric tube will not represent a contraindication for the use of HFNT provided the patency of the used nostril.
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Co-interventions: Patients potentially eligible for the study will be evaluated by the attending physicians and receive medical therapy based on the attending physician's decision and local protocols. Awake proning is allowed. Local protocols, including drugs and awake proning, will be discussed with the enrolling centers at the initiation visit, and adherence to WHO guidelines will be recommended. Written informed consent from all the patients will be collected.
Termination criteria \& protocol violation: Criteria for weaning off COT or HFNT was at clinical discretion of the managing physician based on the improvement in oxygenation with ability to maintain SpO2 of 96% or greater with less than 0.30 of FiO2 or P/F \> 300. The switch from COT to HFNT should be considered a protocol violation and should be based on clinical decision of the treating physician.
Criteria to be considered for escalation of treatment: 1) SpO2 ≤ 92% despite COT or HFNT or P/F ≤ 180 with FiO2 ≥ 50%, and 2) at least one of the following: respiratory rate ≥ 28 breaths/min, severe dyspnea, signs of increased work of breathing (e.g. use of accessory muscles). If the patient meets these criteria, escalation of treatment CPAP, NIV or IMV will be considered.
The choice of the type of escalating treatment will be a clinical decision of the treating physician.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 364
- Age ≥ 18 years old
- Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR) nasopharyngeal swabs
- Clinical signs of acute respiratory infection and radiological evidence of pneumonia
- Hospital admission in any ward or Emergency Department within 48 h
- SpO2 ≤ 92% or PaO2/FiO2 < 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.
- PaO2/FiO2 ≤ 200
- Respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles
- Need for immediate intubation or noninvasive ventilation (including CPAP) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis pH ≤ 7.3)
- Patients already on CPAP/NIV or HFNT at study screening
- Septic shock
- Evidence of multiorgan failure
- Glasgow Coma Scale < 13
- Inability to comprehend the study content and give informed consent
- PaCO2 > 45 mmHg, (if blood gas available) or history of chronic hypercapnia
- Patient already on long-term oxygen therapy (LTOT) or home NIV/CPAP (even if only overnight)
- Neuromuscular disease
- Limitation of care based on patients' or physicians' decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Oxygen Therapy Conventional Oxygen Therapy Conventional Oxygen therapy High Flow Nasal Therapy High Flow Nasal Therapy High flow nasal therapy
- Primary Outcome Measures
Name Time Method Proportion of patients needing escalation of treatment during hospital stay 28 days Proportion of patients needing escalation of treatment (i.e. noninvasive ventilation - including CPAP - or intubation).
- Secondary Outcome Measures
Name Time Method Length of stay in ICU 28 day 60-day mortality 60 days from hospital admission Proportion of patients needing intubation during hospital stay 28 days 28-day mortality 28 days from hospital admission Proportion of patients admitted to intensive care unit during hospital stay 28 days Proportion of patients who receive NIV during hospital stay 28 days Proportion of patients undergone noninvasive ventilation (e.g. BiLevel, PSV)
Proportion of patients who terminate the study protocols for improvement 28 days Length of stay in hospital 28 days Ventilator-free days during hospital stay 28 days Dyspnea score (BORG scale) during hospital stay 28 days \[0= no dyspnea to 10= severe dyspnea\] - daily collection
Days free from CPAP/NIV during hospital stay 28 days ROX index during hospital stay 28 days SpO2/FiO2/Respiratory rate - daily collection
Proportion of patients who receive CPAP during hospital stay 28 days Proportion of patients who receive continuous positive airway pressure during hospital stay
Time to escalation of treatment to CPAP/NIV during hospital stay 28 days Time to escalation of treatment to intubation/invasive ventilation during hospital stay 28 days Oxygen-free days during hospital stay 28 days Hospital mortality 28 days National Early Warning Score 2 (NEWS2) during hospital stay 28 days Daily collection of Six simple physiological parameters that form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. A score is allocated to each parameter, with the magnitude of the score reflecting how extremely the parameter varies from the norm. The score is then aggregated and uplifted by 2 points for people requiring supplemental oxygen to maintain their recommended oxygen saturation. Range of values: 0 (best) - 23 (worst) points.
Treatment interruption due to intolerance during study treatment 28 days
Trial Locations
- Locations (27)
Department of Emergency Medicine, Faculty of Medicine, University of Thessaly
🇬🇷Larisa, Greece
Department of Anesthesiology, University of Thessaly, School of Health Sciences, Faculty of Medicine
🇬🇷Larissa, Greece
U.O. di Medicina interna AULSS 7 Pedemontana
🇮🇹Bassano del Grappa, VI, Italy
Ospedale di Carpi
🇮🇹Carpi, Italy
Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari
🇮🇹Bari, Italy
UO di Pronto Soccorso e Medicina d'Urgenza Humanitas Research Hospital
🇮🇹Rozzano, Milano, Italy
Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
🇮🇹Arezzo, Italy
Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital, Catania, Italy
🇮🇹Catania, Italy
AO DEI COLLI - PO Monaldi UO di Pneumologia e Fisiopatologia Respiratoria
🇮🇹Napoli, Italy
Respiratory Section, Department of Translational Medicine, University of Ferrara. AOU Ferrara Arcispedale S. Anna. U.O. Pneumologia
🇮🇹Ferrara, Italy
UO di Medicina d'Urgenza AOU Policlinico Vittorio Emanuele San Marco di Catania
🇮🇹Catania, Italy
UO di Pneumologia ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
Department of Medical and Surgical Sciences, University of Foggia. Institute of Respiratory Diseases, University Hospital 'Policlinico Riuniti'
🇮🇹Foggia, Italy
AOU San Luigi Gonzaga
🇮🇹Orbassano, Italy
Emergency Department, "S. Maria della Misericordia" Hospital, Perugia, Italy.
🇮🇹Perugia, Italy
U.O. di PneumoCovid Azienda Ospedaliera San Giovanni di Roma
🇮🇹Roma, Italy
U.O. di Pneumologia Azienda USL di Pescara
🇮🇹Pescara, Italy
UO di Pronto Soccorso e Medicina d'Urgenza AUSL Romagna PO Rimini Ospedale "Inferni"
🇮🇹Rimini, Italy
UO di Pneumologia Ospedale S. Bartolomeo
🇮🇹Sarzana, Italy
Department of Pneumology, A.O.U. Città della Salute e della Scienza of Turin, Italy.
🇮🇹Turin, Italy
U.O. di Pneumologia ASST Settelaghi Ospedale Circolo Fondazione Macchi
🇮🇹Varese, Italy
U.O. Medicina Respiratoria del Policlinico G.B. Rossi
🇮🇹Verona, Italy
U.O. di Pneumotisiologia Ospedale di Vittorio Veneto Azienda ULSS 2 Marca Trevigiana
🇮🇹Vittorio Veneto, Italy
Hospital Prof. Doutor Fernando Fonseca, Pneumologia
🇵🇹Amadora, Portugal
Department of Pneumonology, Faculty of Medical Sciences in Katowice, Medical University of Silesia
🇵🇱Katowice, Poland
Dokuz Eylül University
🇹🇷İzmir, Turkey
Hospital Parc Taulí de Sabadell, Pneumologia
🇪🇸Sabadell, Spain