Helmet NIV in Acute Respiratory Failure (HELMET)

Hamilton Health Sciences (HHS)

Status: Active, not recruiting

Conditions: Acute Respiratory Failure

Treatments: Device: Facemask Non-Invasive Ventilation; Device: Helmet Non-Invasive Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05022173

13412

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Helmet NIV

Experimental group

Description:

Patients randomized to the intervention arm will receive NIV through a phthalate free helmet (CaStar, STARMED) via an ICU ventilator in pressure support (PS) mode.

Treatment:

Device: Helmet Non-Invasive Ventilation

Facemask NIV

Active Comparator group

Description:

Patients in the control arm will be randomized to the traditional facemask interface. The facemask group will use the same ICU ventilator being used for the helmet group.

Treatment:

Device: Facemask Non-Invasive Ventilation