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N/A

Helmet NIV for COVID-19 Respiratory Failure

N/A

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20

Adequate gag and cough reflex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial will test whether or not a helmet-based ventilation system can help reduce the amount of time patients with COVID-19 need to be on a ventilator.

Who is the study for?

This trial is for adults over 18 who've been on mechanical ventilation for at least 48 hours due to acute respiratory failure, including COVID-19. They must be able to breathe on their own and have stable blood pressure without heavy reliance on medications. Pregnant individuals, those with severe brain injury or coma, or anyone refusing intubation are excluded.Check my eligibility

What is being tested?

The study tests if helmet non-invasive ventilation (NIV) can reduce the time patients need invasive mechanical breathing support during illnesses like COVID-19 by allowing earlier removal from ventilators while still supporting their breathing needs.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects of helmet NIV may include discomfort wearing the device, skin breakdown around the neck area where it seals, dryness of mouth or throat, and possibly claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breathing support is set to a specific pressure level.

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I can swallow and cough normally.

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I am 18 or older and have been on a ventilator for at least 48 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ventilator days

Secondary outcome measures

Intensive care unit (ICU) length of stay

need for re-intubation

Other outcome measures

ICU related complications

diaphragm thickening fraction

diaphragm ultrasound thickness

+5 more

Trial Design

2Treatment groups

Active Control

Group I: Helmet non invasive ventilation (NIV)Active Control1 Intervention

Patients randomized to the intervention group will be extubated to helmet NIV.

Group II: Control invasive mechanical ventilationActive Control1 Intervention

Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated.

0 / 3Eligibility criteria met