UnknownNot Applicable

A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula

United States1 participantsStarted 2018-06-01

Plain-language summary

Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years
. AHRF defined as:
. Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)

Exclusion criteria

. P/F Ratio \< 100 (Severe ARDS) on quantifiable FiO2
. More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
. Urgent need for intubation
. Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
. Upper airway obstruction, facial trauma
. Copious secretions, airway bleeding, epistaxis or vomiting
. Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma
. Elevated intracranial pressure \>20 mm Hg

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of intubation

Timeframe: 28 days

Trial details

NCT IDNCT04035460

SponsorBaystate Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Hypoxemic Respiratory Failure trials