Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Conditions
Keywords
COPD, NIV, Acute Hypercapnic Respiratory Failure, COPD patients with hypercapnic respiratory failure
Brief 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.
Interventions
DEVICEHelmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
DEVICETotal Face mask (Respironics)
The total face mask is the classical interface for NIV delivery
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pH \< 7,35 and PaCO2 \> 45 mmHg * respiratory rate \> 20 b/min
Exclusion criteria
* hypoxic respiratory failure * coma * inability to stand NIV * lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial Blood gases | at 1 hour after the start of NIV |
Secondary
| Measure | Time frame |
|---|---|
| Arterial Blood Gases | Once a day at 8 am until discharge |
Countries
Italy
Outcome results
None listed