Helmet CPAP Versus HFNC in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-04-12

Brief Summary

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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.

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Detailed Description

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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

Conditions

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COVID Acute Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Helmet CPAP

Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).

Group Type ACTIVE_COMPARATOR

Helmet CPAP

Intervention Type 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.

HFNC

High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)

Group Type ACTIVE_COMPARATOR

HFNC

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No