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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. |
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| Non invasive ventilation via helmet | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non invasive ventilation using a helmet hyperbaric device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Endotracheal Intubation | Number of patients requiring endotracheal intubation after application of helmet device | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Days spent in hospital at time of enrollment | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Complications | ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness | 6 weeks |
| Readmission to the Intensive Care Unit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Kress, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27179847 | Derived | Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
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| Noninvasive ventilation via facemask | Other | Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask |
|
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| 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 | number of days in the hospital |
| Hospital Mortality | Death from any cause during hospitalization at time of enrollment | 90 days |
| Intensive Care Unit Length of Stay | Number of days admitted to a medical intensive care unit | 4 weeks |
Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
| 6 weeks |
| Discharge Location | Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to | 6 weeks |
| Improvement of Oxygenation | Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100 | 2 weeks |
| Non Invasive Ventilation Via Helmet |
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 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask |
| BG001 | Non Invasive Ventilation Via Helmet | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Need for Endotracheal Intubation | Number of patients requiring endotracheal intubation after application of helmet device | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Hospital Length of Stay | Days spent in hospital at time of enrollment | Posted | Median | Inter-Quartile Range | days | Duration of hospital stay |
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| Secondary | 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) | Posted | Count of Participants | Participants | Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization) |
| ||||||||||||||||||||||||||||||||
| Secondary | Ventilator-free Days | Duration of mechanical ventilation via endotracheal tube | Posted | Median | Inter-Quartile Range | days | number of days in the hospital |
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| Secondary | Hospital Mortality | Death from any cause during hospitalization at time of enrollment | Posted | Count of Participants | Participants | 90 days |
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| Secondary | Intensive Care Unit Length of Stay | Number of days admitted to a medical intensive care unit | Posted | Median | Inter-Quartile Range | days | 4 weeks |
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| Other Pre-specified | ICU Complications | ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness | Not Posted | 6 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Readmission to the Intensive Care Unit | Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment | Not Posted | 6 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Discharge Location | Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to | Not Posted | 6 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Improvement of Oxygenation | Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100 | Not Posted | 2 weeks | Participants |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask | 22 | 39 | 0 | 39 | 0 | 39 |
| EG001 | Non Invasive Ventilation Via Helmet | 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 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. | 12 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P. Kress | University of Chicago | 7737026790 | jkress@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012769 | Shock |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D012138 | Respiratory Therapy |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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