HELMET: Helmet NIV in Acute Respiratory Failure

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05022173
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Device: Helmet Non-Invasive Ventilation; Device: Facemask Non-Invasive Ventilation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial
• Actual Study Start Date: Nov 11, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Helmet NIV 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.	Device: Helmet Non-Invasive Ventilation; 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.
Active Comparator: Facemask NIV 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.	Device: Facemask Non-Invasive Ventilation; 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.

Outcome Measures

Primary Outcome Measures

1. Consent Rate [1 year]

   Percentage of patients or SDMs approached for consent who give consent

2. Recruitment Rate [1 year]

   Number of patients recruited to the study per centre

3. Protocol adherence percentage [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 Outcome Measures

1. Endotracheal intubation [28 days]

   Number of patients requiring endotracheal intubation

2. ICU mortality [28 days]

   Number of patients who die in ICU

3. Hospital mortality [60 days]

   Number of patients who die in hospital

4. ICU length of stay [Censored at 28 days]

   Number of days that each patient spends in ICU

5. Hospital length of stay [Censored at 60 days]

   Number of days that each patients spends in hospital

6. Duration of non-invasive ventilation [Censored at 28 days]

   Number of days that patient receives non-invasive ventilation

7. Duration of invasive ventilation [Censored at 28 days]

   Number of days that patient receives invasive ventilation

8. Adverse events [28 days]

   Any complications related to NIV use

9. Comfort [28 days]

   Patient comfort with non-invasive ventilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juravinski Hospital	Hamilton	Ontario	Canada	L8V1C3

Sponsors and Collaborators

• Hamilton Health Sciences Corporation

Investigators

• Principal Investigator: Bram Rochwerg, MD, Hamilton Health Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT05022173
• Other Study ID Numbers: 13412
• First Posted: Aug 26, 2021
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Hamilton Health Sciences Corporation: non-invasive ventilation; Helmet non-invasive ventilation
• Additional relevant MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome

Study Results

No Results Posted as of Jan 20, 2022