Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645358
• Other study ID #: 1222
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2012
• Last updated: October 5, 2014
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• Helmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
• Total Face mask (Respironics)
The total face mask is the "classical" interface for NIV delivery

Locations

Country	Name	City	State
Italy	Sant'Orsola Malpighi	Bologna
Italy	Sant'Orsola malpighi Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Blood gases		at 1 hour after the start of NIV	No
Secondary	Arterial Blood Gases		Once a day at 8 am until discharge	No