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NCT Number: NCT05022173

Helmet NIV in Acute Respiratory Failure

Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Respiratory Failure

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Hospital

Hamilton, Ontario, L8V1C3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) patients who are admitted to the adult ICU
  • 2) deemed to require NIV, as per the clinical team, for acute respiratory failure.

Exclusion criteria

  • 1) with impending cardiac arrest or need for intubation
  • 2) Glasgow coma scale <9
  • 3) tracheostomy or upper airway obstruction
  • 4) elevated intracranial pressure
  • 5) untreated pneumothorax
  • 6) who refuse endotracheal intubation (do not intubate order documented)
  • 7) facial trauma
  • 8) are unable to wear the helmet or facemask
  • 9) who use NIV chronically

Treatment and study plan

Helmet non-invasive ventilation

Device

The helmet interface is a modality which is used to deliver NIV to patients with respiratory failure. A transparent hood is placed over the entire head of the patient with a seal at the neck using a soft collar.

Facemask Non-Invasive Ventilation

Device

The facemask interface is a modality which is also used to deliver NIV to patients with respiratory failure. A large mask covering the mouth and nose is strapped to the patient's face to create a seal.

Primary outcomes

  1. Consent Rate

    Time frame: 1 year

    Percentage of patients or SDMs approached for consent who give consent

  2. Recruitment Rate

    Time frame: 1 year

    Number of patients recruited to the study per centre

  3. Protocol adherence percentage

    Time frame: 1 year

    Adherence to pre-specified fixed protocol on how helmet interface is implemented (settings, weaning etc.) Any protocol deviations will be recorded and marked as protocol non-adherence.

Secondary outcomes

  1. Endotracheal intubation

    Time frame: 28 days

    Number of patients requiring endotracheal intubation

  2. ICU mortality

    Time frame: 28 days

    Number of patients who die in ICU

  3. Hospital mortality

    Time frame: 60 days

    Number of patients who die in hospital

  4. ICU length of stay

    Time frame: Censored at 28 days

    Number of days that each patient spends in ICU

  5. Hospital length of stay

    Time frame: Censored at 60 days

    Number of days that each patients spends in hospital

  6. Duration of non-invasive ventilation

    Time frame: Censored at 28 days

    Number of days that patient receives non-invasive ventilation

  7. Duration of invasive ventilation

    Time frame: Censored at 28 days

    Number of days that patient receives invasive ventilation

  8. Adverse events

    Time frame: 28 days

    Any complications related to NIV use

  9. Comfort

    Time frame: 28 days

    Patient comfort with non-invasive ventilation

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial

Acronym: HELMET

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2021
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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