Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Skane | OTHER |
Not provided
Not provided
Not provided
Not provided
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
A detailed description can be found in the study protocol published in Trials in Dec 2020:
Tverring, J., Åkesson, A. & Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet CPAP | Active Comparator | Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices). |
|
| HFNC | Active Comparator | High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet CPAP | Device | Start-up air flow 40 L/min. Start-up PEEP 5 cmH2O. Max PEEP 20 cmH2O. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-Free Days (VFD) | Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2/FiO2-ratio | Peripheral oxygen saturation divided by fraction of inspired oxygen | 1 hour after randomisation |
| Patient comfort | Visual scale (1-10) |
Not provided
Inclusion Criteria (all of the following):
Exclusion Criteria (any of the following):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonas Tverring, MD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborg's Hospital | Helsingborg | Region Skane | 252 23 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33272319 | Derived | Tverring J, Akesson A, Nielsen N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials. 2020 Dec 3;21(1):994. doi: 10.1186/s13063-020-04863-5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HFNC | Device | Start-up air flow 30 L/min. Max air flow 60 L/min. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice. |
|
| 24 hours after randomisation |
| Frequency of endotracheal intubation | Min 0, Max 1 | 28 days |
| Frequency of carbon dioxide rebreathing | Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max ∞ | 28 days |
| Days alive within | All-cause mortality. (180 days endpoint not in primary publication) | 28 days and 180 days |