What is the mechanism of action of this treatment?

Mechanical ventilation treatments, including invasive mechanical ventilation and non-invasive ventilation (NIV) such as helmet NIV, work by supporting or replacing the patient's spontaneous breathing to improve oxygenation and reduce the work of breathing. Invasive mechanical ventilation involves the use of an endotracheal tube to deliver controlled breaths directly to the lungs, ensuring adequate gas exchange. Non-invasive ventilation, like helmet NIV, uses a sealed helmet interface to provide positive pressure ventilation, which can enhance oxygenation and reduce the effort required to breathe without the need for intubation. These treatments are crucial for patients with respiratory failure as they help maintain adequate oxygen levels, reduce respiratory muscle fatigue, and improve overall patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for mechanical ventilation, including Helmet NIV, can have several side effects. These may include discomfort or skin breakdown due to the helmet interface, claustrophobia, and difficulty in communication. Additionally, there is a risk of aspiration, gastric distension, and, in some cases, barotrauma or volutrauma due to improper pressure settings. It is essential for healthcare providers to monitor patients closely to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved various treatments for mechanical ventilation, primarily focusing on improving oxygenation and reducing the work of breathing. While specific FDA approvals for Helmet NIV are not detailed, non-invasive ventilation (NIV) methods, including CPAP (Continuous Positive Airway Pressure) and BiPAP (Bilevel Positive Airway Pressure), are commonly used and have been approved for managing respiratory failure. These methods aim to enhance patient comfort and reduce the need for invasive mechanical ventilation.

What other types of research exist?

Promising novel alternatives to Helmet NIV for mechanical ventilation patients include: <ol> <li>Inhaled nitric oxide, which has been studied for its potential to improve oxygenation in ARDS patients.</li> <li></li> </ol> Inhaled epoprostenol, another agent compared to nitric oxide for its effects on oxygenation. 3. Prone positioning, which has been shown to improve survival and oxygenation in ARDS patients. 4. Noninvasive ventilatory support modes such as proportional assist ventilation, which may reduce patient-ventilator asynchrony and improve sleep quality. 5. High-frequency chest wall oscillation, which has been studied for airway clearance and may indirectly support better ventilation.

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N/A

Helmet NIV for COVID-19 Respiratory Failure

N/A

Waitlist Available

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mechanical ventilation treatments, including invasive mechanical ventilation and non-invasive ventilation (NIV) such as helmet NIV, work by supporting or replacing the patient's spontaneous breathing to improve oxygenation and reduce the work of breathing. Invasive mechanical ventilation involves the use of an endotracheal tube to deliver controlled breaths directly to the lungs, ensuring adequate gas exchange. Non-invasive ventilation, like helmet NIV, uses a sealed helmet interface to provide positive pressure ventilation, which can enhance oxygenation and reduce the effort required to breathe without the need for intubation. These treatments are crucial for patients with respiratory failure as they help maintain adequate oxygen levels, reduce respiratory muscle fatigue, and improve overall patient outcomes.

Stakeholder Engagement in Trial Design: Survey of Visitors to Critically Ill Patients Regarding Preferences for Outcomes and Treatment Options during Weaning from Mechanical Ventilation.