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Helmet Ventilation in Acute Hypercapnic Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01645358
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.


Condition or disease Intervention/treatment Phase
Hypercapnic Respiratory Failure Chronic Obstructive Pulmonary Disease Device: Helmet (Starmed) Device: Total Face mask (Respironics) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"
Study Start Date : July 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Helmet to deliver NIV Device: Helmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
Other Name: Starmed Helmet
Active Comparator: Total Face to deliver NIV Device: Total Face mask (Respironics)
The total face mask is the "classical" interface for NIV delivery
Other Name: Respironics Performax or similar



Primary Outcome Measures :
  1. Arterial Blood gases [ Time Frame: at 1 hour after the start of NIV ]

Secondary Outcome Measures :
  1. Arterial Blood Gases [ Time Frame: Once a day at 8 am until discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645358


Locations
Italy
Sant'Orsola malpighi Hospital
Bologna, Italy, 40185
Sant'Orsola Malpighi
Bologna, Italy, 40185
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr. Stefano Nava, Chief Respiratory and Critical care, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01645358     History of Changes
Other Study ID Numbers: 1222
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
COPD
NIV
Acute Hypercapnic Respiratory Failure
COPD patients with hypercapnic respiratory failure

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Hypercapnia
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms