Clinical trial NCT01680783: Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
Official title: Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Shock
Ventilatory Failure
Cardiogenic Pulmonary Edema
Keywords: noninvasive ventilation
acute hypoxemic respiratory failure
Acute respiratory distress syndrome
shock
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for Endotracheal Intubation
timeFrame: 6 weeks
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Duration of hospital stay
measure: Number of Participants Functional Status After Discharge
timeFrame: Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)
measure: Ventilator-free Days
timeFrame: number of days in the hospital
measure: Hospital Mortality
timeFrame: 90 days
measure: Intensive Care Unit Length of Stay
timeFrame: 4 weeks
Other outcomes:
measure: ICU Complications
timeFrame: 6 weeks
measure: Readmission to the Intensive Care Unit
timeFrame: 6 weeks
measure: Discharge Location
timeFrame: 6 weeks
measure: Improvement of Oxygenation
timeFrame: 2 weeks
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.