An interventional study of Non invasive ventilation using a helmet hyperbaric device and Noninvasive ventilation via facemask in Acute Respiratory Distress Syndrome, Shock and Ventilatory Failure, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
Respiratory failure is often treated with endotracheal intubation and mechanical ventilation. Although, the institution of mechanical ventilation is considered life saving, the associated complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and neuromuscular weakness are not without considerable morbidity and mortality.
Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory failure in immunocompromised patients.
Despite the advantages of non-invasive ventilation via facemask, some patients fail because of mask intolerance and severity of disease. Further limitation to facemask non-invasive ventilation is that the seal integrity is lost when higher pressures are required. Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock may require such higher pressures.
In an attempt to improve patient tolerability and deliver higher pressures, a transparent helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the entire head and neck of the patient. The design of the helmet confers some important advantages: 1) the transparency allows the patient to interact with the environment; 2) the lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems of leaking with higher airway pressures that are seen with the face mask; 4) it can be applied to any patient regardless of facial contour.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 83 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Other: Noninvasive ventilation via facemask
Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Device: Non invasive ventilation using a helmet hyperbaric device
Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Also known as: Sea-Long medical treatment hood
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
Also known as: mechanical ventilation
Need for Endotracheal Intubation
Number of patients requiring endotracheal intubation after application of helmet device
Time frame: 6 weeks
Hospital Length of Stay
Days spent in hospital at time of enrollment
Time frame: Duration of hospital stay
Number of Participants Functional Status After Discharge
Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
Time frame: Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)
Ventilator-free Days
Duration of mechanical ventilation via endotracheal tube
Time frame: number of days in the hospital
Hospital Mortality
Death from any cause during hospitalization at time of enrollment
Time frame: 90 days
Intensive Care Unit Length of Stay
Number of days admitted to a medical intensive care unit
Time frame: 4 weeks
ICU Complications
ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
Time frame: 6 weeks
Readmission to the Intensive Care Unit
Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
Time frame: 6 weeks
Discharge Location
Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
Time frame: 6 weeks
Improvement of Oxygenation
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Time frame: 2 weeks
| Milestone | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Started | 39 | 44 |
| Completed | 39 | 44 |
| Not completed | 0 | 0 |
Number of patients requiring endotracheal intubation after application of helmet device
| Participants | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Need for Endotracheal Intubation | 24 | 8 |
Days spent in hospital at time of enrollment
| days | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Hospital Length of Stay | 15.2 (7.8 to 19.7) | 10.1 (6.5 to 15.9) |
Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
| Participants | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Number of Participants Functional Status After Discharge | 6 | 22 |
Duration of mechanical ventilation via endotracheal tube
| days | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Ventilator-free Days | 12.5 (0.49 to 28) | 28 (13.7 to 28) |
Death from any cause during hospitalization at time of enrollment
| Participants | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Hospital Mortality | 19 | 12 |
Number of days admitted to a medical intensive care unit
| days | Usual Care | Non Invasive Ventilation Via Helmet |
|---|---|---|
| Intensive Care Unit Length of Stay | 7.8 (3.9 to 13.8) | 4.7 (2.5 to 8.7) |
ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
Results for this outcome have not been posted.
Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
Results for this outcome have not been posted.
Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
Results for this outcome have not been posted.
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 22/39 (56.4%) | 0/39 (0%) | 0/39 (0%) |
| Non Invasive Ventilation Via Helmet | 12/44 (27.3%) | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Usual Care | Non Invasive Ventilation Via Helmet | Total |
|---|---|---|---|
| Median | 60.9 (56.4 to 71.1) | 58 (49.8 to 67.8) | 59 (52 to 69) |
| Sex: Female, Male(Participants) | Usual Care | Non Invasive Ventilation Via Helmet | Total |
|---|---|---|---|
| Female | 18 | 20 | 38 |
| Male | 21 | 24 | 45 |
| Race (NIH/OMB)(Participants) | Usual Care | Non Invasive Ventilation Via Helmet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 28 | 50 |
| White | 16 | 14 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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