Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1
The helmet encloses the head and neck of the patient, has a rigid ring and is secured by 2 armpit braces. A soft collar adheres to the neck and ensures a sealed connection once the helmet is inflated.
Large-bore nasal prongs through which oxygen is delivered at high flow rates
Baystate Medical Center
Springfield, Massachusetts, United States
Rate of intubation
To determine the rates of intubation for subjects with Acute Hypoxemic Respiratory Failure (AHRF) managed by non-invasive modalities High Flow Nasal Cannula (HFNC) and Helmet NIPPV.
Time frame: 28 days
Time to intubation
Hours and minutes from time of initiation of protocol until intubation
Time frame: 28 days
Intubation-free days through day 28
number of days from the time of randomization to day 28 after randomization on which the patient is not intubated and does not require invasive mechanical ventilation
Time frame: 28 days
Organ-failure-free days through day 28
Daily determination of presence or absence of Cardiovascular, Kidney, Liver, Central Nervous System, and Hematological Dysfunction.
Time frame: 28 days
Mortality prior to discharge from hospital (up to study day 90 whichever comes first)
hospital mortality
Time frame: 90 days
Hospital mortality to day 28
hospital mortality
Time frame: 28 days
ICU free-days to day 28
days not in ICU
Time frame: 28 days
Hospital length of stay
duration of hospital stay
Time frame: 28 days
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Rate of cross-over between groups
The percentage of patients in each group crossed over to the alternative group or another form of noninvasive ventilation.
Time frame: 28 days
Complications
Adverse events other than failure of the noninvasive oxygenation device
Time frame: 28 days
Ventilator associated pneumonia, barotrauma
Complications due to mechanical ventilation
Time frame: 28 days
Total daily dose of sedative medications (milligram)
Assessment of Sedation medications
Time frame: 7 days
Highest level of daily mobility through day 7
Activity level
Time frame: 7 days
Tolerance of the devices
Daily assessment with visual analog scale for comfort, range 0-5, with 0= no discomfort and 5=unable to tolerate
Time frame: 28 days
Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC
Reasons for exclusion of patients meeting inclusion criteria
Time frame: through study completion, an average of 1 year
Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria
Usual care comparison
Time frame: 28 days
Richmond Agitation and Sedation Scale (RASS)
Highest daily RASS score. The scale range is -5 to +4 in integer increments, Where -5 is unarousable, 0 is alert and calm, and +4 is combative
Time frame: 7 days
Confusion Assessment Method for the ICU (CAM-ICU)
Daily assessment of presence or absence of delirium
Time frame: 7 days