Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure

The University of Chicago

Status: Completed

Conditions: Ventilatory Failure; Shock; Acute Respiratory Distress Syndrome; Cardiogenic Pulmonary Edema

Treatments: Device: Non invasive ventilation using a helmet hyperbaric device; Other: Noninvasive ventilation via facemask

Study type: Interventional

Funder types: Other

Identifiers

NCT01680783

12-1391

Details and patient eligibility

About

The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Usual Care

Other group

Description:

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

Treatment:

Other: Noninvasive ventilation via facemask

Non invasive ventilation via helmet

Experimental group

Description:

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

Treatment:

Device: Non invasive ventilation using a helmet hyperbaric device