Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
15 participants
INTERVENTIONAL
2021-11-11
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers
NCT01610960
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome
NCT04507802
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
NCT04035460
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
NCT01680783
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
NCT05078034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2\) deemed to require NIV, as per the clinical team, for acute respiratory failure.
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hamilton Health Sciences Corporation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bram Rochwerg, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Science
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Juravinski Hospital
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13412
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.