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Helmet Ventilation in Acute Hypercapnic Respiratory Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01645358
First Posted: July 20, 2012
Last Update Posted: October 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  Purpose

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

Study Type: Interventional
Study Design: 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?"

Resource links provided by NLM:


Further study details as provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

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

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

Enrollment: 80
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: March 22, 2012
First Posted: July 20, 2012
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