Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | February 14, 2012 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Arterial blood gases | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00213395 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort. Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations. The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Acute Hypercapnic Respiratory Failure | ||||
| Intervention ICMJE | Device: Interface for noninvasive ventilation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00213395 | ||||
| Other Study ID Numbers ICMJE | 2004/015/HP | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Rouen | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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