NCT01645358

Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated. In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.

Conditions

• Hypercapnic Respiratory Failure
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Helmet (Starmed)	The helmet is a kind of interface similar to a hood to deliver NIV
DEVICE	Total Face mask (Respironics)	The total face mask is the "classical" interface for NIV delivery

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-07-20
• Last updated: 2014-10-07

Locations

2 sites across 1 country: Italy