Helmet Ventilation in Acute Hypercapnic Respiratory Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01645358
First received: March 22, 2012
Last updated: January 25, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial Blood Gases [ Time Frame: Once a day at 8 am until discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645358

Contacts
Contact: Stefano nava, MD 0516364017 stefanava@gmail.com
Contact: Luca Fasano, MD

Locations
Italy
Sant'Orsola malpighi Hospital Not yet recruiting
Bologna, Italy, 40185
Contact: Stefano Nava, MD    0516364017    stefanava@gmail.com   
Contact: Luca Fasano, MD         
Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40185
Contact: Stefano Nava, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  More Information

No publications provided

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
Study First Received: March 22, 2012
Last Updated: January 25, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by 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, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Insufficiency
Hypercapnia
Hypoventilation
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014