Helmet Non-Invasive Ventilation for Respiratory Distress Syndrome

Phase-Based Progress Estimates
Juravinski Hospital, Hamilton, Canada
Respiratory Distress Syndrome+2 More
Helmet Non-Invasive Ventilation - Device
Any Age
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.

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Eligible Conditions

  • Respiratory Distress Syndrome
  • Acute Respiratory Failure

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Helmet Non-Invasive Ventilation will improve 3 primary outcomes and 9 secondary outcomes in patients with Respiratory Distress Syndrome. Measurement will happen over the course of Censored at 28 days.

1 year
Consent Rate
Protocol adherence percentage
Recruitment Rate
28 days
Adverse events
Endotracheal intubation
ICU mortality
60 days
Hospital mortality
Censored at 28 days
Duration of invasive ventilation
Duration of non-invasive ventilation
ICU length of stay
Censored at 60 days
Hospital length of stay

Trial Safety

Trial Design

2 Treatment Groups

Facemask NIV
1 of 2
Helmet NIV
1 of 2
Active Control
Experimental Treatment

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Helmet Non-Invasive Ventilation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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.
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Juravinski Hospital - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
are often very sick Many patients who are admitted to the adult ICU are very sick. show original
The clinical team has determined that the patient requires NIV for acute respiratory failure. show original

Patient Q&A Section

What causes respiratory failure?

"Severe respiratory failure can result from a variety of illnesses and is likely to be multifactorial in its underlying causation. A better understanding of the underlying mechanisms of the injury will lead to a better understanding of how to prevent respiratory failure." - Anonymous Online Contributor

Unverified Answer

Can respiratory failure be cured?

"If given aggressive medical treatment, the respiratory failure that is common with severe illness and trauma may be managed with remarkable success. This is particularly so when the patient can be shifted to a specialized respiratory therapy unit." - Anonymous Online Contributor

Unverified Answer

What are common treatments for respiratory failure?

"Ventilatory support with continuous positive airway pressure may improve survival when compared to continuous positive airway pressure with supplemental oxygen. In addition, a lower peak inspiratory pressure with oxygen compared to oxygen alone is recommended when ventilation with oxygen is given. The use of the non-invasive airway adjuncts laryngeal mask airway (tracheal tube) or oropharyngeal mask airway is associated with improved outcomes." - Anonymous Online Contributor

Unverified Answer

What are the signs of respiratory failure?

"In patients presenting to the emergency department with severe respiratory failure, early detection and aggressive respiratory therapy are crucial. The identification and timely treatment of underlying cause are critical for successful management." - Anonymous Online Contributor

Unverified Answer

What is respiratory failure?

"This definition is commonly used in emergency medicine, and its use in clinical trials is appropriate. Whether ventilation for respiratory failure was a primary aim or not, it remains a common issue for patients who require mechanical ventilation. The definition of'respiratory failure' remains valid for clinical trials of ventilators in patients with acute respiratory failure." - Anonymous Online Contributor

Unverified Answer

How many people get respiratory failure a year in the United States?

"In the United States, an estimated 47,400 people have a respiratory failure-related hospitalization every year. This represents a rate of 10% of all hospitalizations or a mean of 2.8 admissions per 1000 persons/year. These numbers can easily be transformed to more commonly used measures of disease frequency per year based on age and sex, as in the table below: (1) Total incidence of respiratory failure among U.S. adults per year: 47,400 per year; (2) Respiratory rate in hospitalized adults, per 1000 persons/year: 2.8; (3) Respiratory rate in U.S. hospital adults, per 1000 persons/year: 11.76." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for respiratory failure?

"According to this review, the inclusion of a patient in a trial will only improve that patient's disease-free survival if the patient and his or her doctor agree to the clinical trial protocol. It also indicates that clinical trials should focus on trials with more stringent eligibility criteria than have been used until recently because patients with moderate to severe respiratory failure might more often have diseases that would result in a survival benefit from a trial, which may be less effective than standard therapies." - Anonymous Online Contributor

Unverified Answer

Is helmet non-invasive ventilation safe for people?

"Overall, helmet NIV was well tolerated. However, it is recommended that inpatient NIV treatment be discontinued if possible before conversion to in-hospital NIV. The NIV delivered in the helmet and non-invasive respiratory support devices may be recommended as alternatives to NIPPV if long-term oxygen-treatment is required for people with severe CHF." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of helmet non-invasive ventilation?

"Helmet NIV is associated with a range of adverse events, common in patients undergoing prolonged or continuous NIV which may be associated with patient fatigue. These include worsening or development of dyspnea and pneumonia. A multidisciplinary care plan should be developed to minimize these events and promote NIV use continuously in the interests of patient safety." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving helmet non-invasive ventilation?

"Most studies use patients with acute respiratory failure associated with multiple organ dysfunction and a low probability of survival. The design of these trials is not well-suited for patients with chronic respiratory failure and no other organ dysfunction. It is therefore relevant to compare helmet non-invasive ventilation in patients with severe acute respiratory failure. In a recent study, findings, we found a low level of evidence for survival advantage of non-invasive ventilation. For the patients with severe acute respiratory failure, there is only low and variable level of evidence that a helmet non-invasive ventilation approach for a minimum of five days had a positive impact on survival." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in helmet non-invasive ventilation for therapeutic use?

"helmet non-invasive ventilation achieves a high percentage of weaning from conventional mechanical ventilators, although there is the need for future refinement of technology so that the risk of air leak related to helmet pressure adjustments can be minimized in conjunction with a sufficiently short circuit-time. The high percentage of successful weaning was also shown within the clinical parameters in the current investigation, the primary outcome measure. Further validation, also in a larger patient population, seems advisable. Prospective studies are warranted." - Anonymous Online Contributor

Unverified Answer

Does helmet non-invasive ventilation improve quality of life for those with respiratory failure?

"The use of NIV over time improves the patient's quality of life but does not alter their daily functioning. Results from a recent paper support the routine use of NIV for long-term home care for patients with chronic obstructive pulmonary disease and may reduce admissions to hospital and reduce costs." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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