NCT01680783

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

Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome
• Shock
• Ventilatory Failure
• Cardiogenic Pulmonary Edema

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Noninvasive ventilation via facemask	Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-09-07
• Last updated: 2020-07-14
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States