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Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00686257
First received: May 27, 2008
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
Results First Received: May 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Respiratory Insufficiency
Interventions: Device: Total face mask (interface for NPPV)
Device: Comfort full or RT040 oronasal mask (interface for NPPV)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Total Face Mask Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
Standard Face Mask Controls Patients receiving NPPV by 'standard oronasal mask'

Participant Flow:   Overall Study
    Total Face Mask     Standard Face Mask Controls  
STARTED     29     31  
COMPLETED     29     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Total Face Mask Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
Standard Face Mask Controls Patients receiving NPPV by 'standard oronasal mask'
Total Total of all reporting groups

Baseline Measures
    Total Face Mask     Standard Face Mask Controls     Total  
Number of Participants  
[units: participants]
 		  29     31     60  
Age  
[units: years]
Mean ± Standard Deviation 		  63.4  ± 15     62.6  ± 17     62.9  ± 9  
Gender  
[units: participants]
 		     
Female     14     17     31  
Male     15     14     29  
Region of Enrollment  
[units: participants]
 		     
United States     29     31     60  



  Outcome Measures

1.  Primary:   Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)   [ Time Frame: During the first 3 hours of recruitment ]
  Show Outcome Measure 1

2.  Primary:   Time Required for Mask Placement   [ Time Frame: at the initiation of NPPV ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Early NPPV Discontinuation Rate   [ Time Frame: During hospitalization period (after recruitment into the study) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Changes in Vital Signs   [ Time Frame: during the first 24 hours of the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Gas Exchange   [ Time Frame: during the first 24 hours of the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Total Length of Time Requiring NPPV   [ Time Frame: during hospitalization (after recruitment) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Dyspnea   [ Time Frame: During the first 3 hours of recruitment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Length of Hospital Stay   [ Time Frame: during hospitalization (after recruitment) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   In-hospital Mortality Rate   [ Time Frame: during hospitalization (after recruitment) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Could not blind subjects or investigators  


Results Point of Contact:  
Name/Title: Nicholas Hill MD
Organization: Tufts Medical Center
phone: 617-636-4288
e-mail: nhill@tuftsmedicalcenter.org


Publications of Results:


Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00686257     History of Changes
Other Study ID Numbers: IRB-6060
Study First Received: May 27, 2008
Results First Received: May 30, 2012
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board