Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Phase 4

Completed

• Conditions: Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease
• Interventions: Device: Helmet (Starmed); Device: Total Face mask (Respironics)

• Registration Number: NCT01645358
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-05
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet to deliver NIV	Helmet (Starmed)	-
Total Face to deliver NIV	Total Face mask (Respironics)	-

Primary Outcome Measures

Name	Time	Method
Arterial Blood gases	at 1 hour after the start of NIV

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gases	Once a day at 8 am until discharge

Trial Locations

Locations (2)

Sant'Orsola malpighi Hospital; 🇮🇹 Bologna, Italy

Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy