Acute Respiratory Distress Syndrome, Cardiogenic Pulmonary Edema, Shock, Ventilatory Failure
Conditions
Keywords
noninvasive ventilation, acute hypoxemic respiratory failure, Acute respiratory distress syndrome, shock
Brief summary
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
Detailed description
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.
Interventions
DEVICENon 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.
OTHERNoninvasive ventilation via facemask
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years of age who require noninvasive ventilation via facemask for \>8hours * Intact airway protective gag reflex * Able to follow instructions
Exclusion criteria
* Cardiopulmonary arrest * Glasgow coma scale \<8 * Absence of airway protective gag reflex * Elevated intracranial pressure * Tracheostomy * Upper airway obstruction * Pregnancy. * Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Endotracheal Intubation | 6 weeks | Number of patients requiring endotracheal intubation after application of helmet device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Duration of hospital stay | Days spent in hospital at time of enrollment |
| Intensive Care Unit Length of Stay | 4 weeks | Number of days admitted to a medical intensive care unit |
| Number of Participants Functional Status After Discharge | Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization) | 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) |
| Ventilator-free Days | number of days in the hospital | Duration of mechanical ventilation via endotracheal tube |
| Hospital Mortality | 90 days | Death from any cause during hospitalization at time of enrollment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Discharge Location | 6 weeks | Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to |
| Improvement of Oxygenation | 2 weeks | Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100 |
| Readmission to the Intensive Care Unit | 6 weeks | Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment |
| ICU Complications | 6 weeks | ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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. | 44 |
| Total | 83 |
Baseline characteristics
| Characteristic | Non Invasive Ventilation Via Helmet | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 58 years | 59 years | 60.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 50 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 24 Participants | 45 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 22 / 39 | 12 / 44 |
| other Total, other adverse events | 0 / 39 | 0 / 44 |
| serious Total, serious adverse events | 0 / 39 | 0 / 44 |
Outcome results
Primary
Need for Endotracheal Intubation
Number of patients requiring endotracheal intubation after application of helmet device
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Need for Endotracheal Intubation | 24 Participants |
| Non Invasive Ventilation Via Helmet | Need for Endotracheal Intubation | 8 Participants |
Secondary
Hospital Length of Stay
Days spent in hospital at time of enrollment
Time frame: Duration of hospital stay
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Hospital Length of Stay | 15.2 days |
| Non Invasive Ventilation Via Helmet | Hospital Length of Stay | 10.1 days |
Secondary
Hospital Mortality
Death from any cause during hospitalization at time of enrollment
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Hospital Mortality | 19 Participants |
| Non Invasive Ventilation Via Helmet | Hospital Mortality | 12 Participants |
Secondary
Intensive Care Unit Length of Stay
Number of days admitted to a medical intensive care unit
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Intensive Care Unit Length of Stay | 7.8 days |
| Non Invasive Ventilation Via Helmet | Intensive Care Unit Length of Stay | 4.7 days |
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)
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Functional Status After Discharge | 6 Participants |
| Non Invasive Ventilation Via Helmet | Number of Participants Functional Status After Discharge | 22 Participants |
Secondary
Ventilator-free Days
Duration of mechanical ventilation via endotracheal tube
Time frame: number of days in the hospital
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Ventilator-free Days | 12.5 days |
| Non Invasive Ventilation Via Helmet | Ventilator-free Days | 28 days |
Other Pre-specified
Discharge Location
Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
Time frame: 6 weeks
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
Time frame: 6 weeks
Other Pre-specified
Improvement of Oxygenation
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Time frame: 2 weeks
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
Time frame: 6 weeks