- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645358
Helmet Ventilation in Acute Hypercapnic Respiratory Failure
Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40185
- Sant'Orsola Malpighi
-
Bologna, Italy, 40185
- sant'orsola malpighi hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Helmet to deliver NIV
|
The helmet is a kind of interface similar to a hood to deliver NIV
Other Names:
|
Active Comparator: Total Face to deliver NIV
|
The total face mask is the "classical" interface for NIV delivery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial Blood gases
Time Frame: at 1 hour after the start of NIV
|
at 1 hour after the start of NIV
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial Blood Gases
Time Frame: Once a day at 8 am until discharge
|
Once a day at 8 am until discharge
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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