Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655638
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-12-03
Brief Title:
HFNT vs COT in COVID-19
Sponsor:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Organization:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study Overview
Official Title:
High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19 A Randomized Controlled Trial The COVID-HIGH Trial
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-HIGH
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 Lmin and potentially increased up to 60 Lmin according to patient tolerance Large-bore nasal prongs will be selected according to the size of patients nostrils ie 23 of the diameter of the patients nostril A surgical mask will be placed on top of the HFNT interface The temperature will be set at 37C or 34 C according to the patients 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 physicians 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 030 of FiO2 or PF 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 PF 180 with FiO2 50 and 2 at least one of the following respiratory rate 28 breathsmin severe dyspnea signs of increased work of breathing eg 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
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 Lmin and potentially increased up to 60 Lmin according to patient tolerance Large-bore nasal prongs will be selected according to the size of patients nostrils ie 23 of the diameter of the patients nostril A surgical mask will be placed on top of the HFNT interface The temperature will be set at 37C or 34 C according to the patients 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 physicians 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 030 of FiO2 or PF 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 PF 180 with FiO2 50 and 2 at least one of the following respiratory rate 28 breathsmin severe dyspnea signs of increased work of breathing eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None