Helmet CPAP Versus HFNC in COVID-19

COVID Clinical Trial

— COVID HELMET  

Official title:

Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04395807
• Other study ID #: COVID HELMET
• Status: Terminated
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: April 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (all of the following):

1. Age = 18 years

2. Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode

3. Peripheral oxygen saturation (SpO2) < 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min

4. A decision to initiate HFNC or Helmet CPAP by the attending ward physician

5. The patient has given written informed consent to participate.

Exclusion Criteria (any of the following):

1. Need for direct admission to the intensive care unit for mechanical ventilation

2. Unconsciousness or drowsiness

3. Pneumothorax

4. Carbon dioxide pressure (pCO2) > 6 kPa in venous blood gas (VBG)

5. Underlying chronic obstructive pulmonary disease stage III-IV

6. A decision not to participate

7. Inability to comprehend the study content and give informed consent

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• COVID
• Respiratory Insufficiency

Intervention

Device:
• Helmet CPAP
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.
• HFNC
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.

Locations

Country	Name	City	State
Sweden	Helsingborg's Hospital	Helsingborg	Region Skane

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	SpO2/FiO2-ratio	Peripheral oxygen saturation divided by fraction of inspired oxygen	1 hour after randomisation
Secondary	Patient comfort	Visual scale (1-10)	24 hours after randomisation
Secondary	Frequency of endotracheal intubation	Min 0, Max 1	28 days
Secondary	Frequency of carbon dioxide rebreathing	Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max 8	28 days
Secondary	Days alive within	All-cause mortality. (180 days endpoint not in primary publication)	28 days and 180 days