Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: Total Face mask (Respironics); Device: Helmet (Starmed)

Study type: Interventional

Funder types: Other

Identifiers

NCT01645358

1222

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Helmet to deliver NIV

Experimental group

Treatment:

Device: Helmet (Starmed)

Total Face to deliver NIV

Active Comparator group

Treatment:

Device: Total Face mask (Respironics)