Helmet CPAP Versus HFNC in COVID-19

Lund University2 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COVID Acute Hypoxemic Respiratory Failure

Interventions

Helmet CPAPDEVICE

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.

HFNCDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsingborg's Hospital

Helsingborg, Region Skane, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Secondary Outcomes

SpO2/FiO2-ratio

Peripheral oxygen saturation divided by fraction of inspired oxygen

Time frame: 1 hour after randomisation

Patient comfort

Visual scale (1-10)

Time frame: 24 hours after randomisation

Frequency of endotracheal intubation

Min 0, Max 1

Time frame: 28 days

Frequency of carbon dioxide rebreathing

Defined as pCO2 \> 6 kPa in a venous blood gas. Min 0, Max ∞

Time frame: 28 days

Days alive within

All-cause mortality. (180 days endpoint not in primary publication)

Time frame: 28 days and 180 days

Data from ClinicalTrials.gov

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