Helmet CPAP Versus HFNC in COVID-19

NCT04395807 | Terminated

• 1 other identifier: COVID HELMET
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID; Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• SpO2/FiO2-ratio

  1 hour after randomisation

• Patient comfort

  24 hours after randomisation

• Frequency of endotracheal intubation

  28 days

• Frequency of carbon dioxide rebreathing

  28 days

• Days alive within

  28 days and 180 days

Study Arms (2)

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).

Device: Helmet CPAP

HFNC

ACTIVE COMPARATOR

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

Device: HFNC

Interventions

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.

Helmet CPAP

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.

HFNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode
• Peripheral oxygen saturation (SpO2) \< 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min
• A decision to initiate HFNC or Helmet CPAP by the attending ward physician
• The patient has given written informed consent to participate.

You may not qualify if:

• Need for direct admission to the intensive care unit for mechanical ventilation
• Unconsciousness or drowsiness
• Pneumothorax
• Carbon dioxide pressure (pCO2) \> 6 kPa in venous blood gas (VBG)
• Underlying chronic obstructive pulmonary disease stage III-IV
• A decision not to participate
• Inability to comprehend the study content and give informed consent

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

Helsingborg's Hospital

Helsingborg, Region Skane, 252 23, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33272319 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jonas Tverring, MD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 20, 2020
• Study Start: June 3, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

SE (1)