Trial Outcomes & Findings for Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure (NCT NCT00686257)

NCT ID: NCT00686257

Last Updated: 2018-06-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: During the first 3 hours of recruitment
• Results posted on: 2018-06-25

Participant Flow

Participant milestones

Measure	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'
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Face Mask n=29 Participants Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls	Standard Face Mask Controls n=31 Participants Patients receiving NPPV by 'standard oronasal mask'	Total n=60 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 15 • n=5 Participants	62.6 years STANDARD_DEVIATION 17 • n=7 Participants	62.9 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: During the first 3 hours of recruitment

Population: By power analysis

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)	3.2 units on a scale Standard Error 0.6	3.3 units on a scale Standard Error 0.7

PRIMARY outcome

Timeframe: at the initiation of NPPV

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Time Required for Mask Placement	5 Minutes Interval 2.0 to 8.0	3.5 Minutes Interval 1.9 to 5.0

SECONDARY outcome

Timeframe: During hospitalization period (after recruitment into the study)

Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Early NIV Discontinuation Rate	12 Participants	16 Participants

SECONDARY outcome

Timeframe: during the first 24 hours of the study

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Deterioration Vital Signs	7 Participants	3 Participants

SECONDARY outcome

Timeframe: during the first 24 hours of the study

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Deterioration in Gas Exchange	3 Participants	3 Participants

SECONDARY outcome

Timeframe: during hospitalization (after recruitment)

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Total Length of Time Requiring NIV	15.7 Hours Interval 4.0 to 49.8	6.05 Hours Interval 0.9 to 56.7

SECONDARY outcome

Timeframe: during hospitalization (after recruitment)

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
Length of Hospital Stay	19.2 Days Interval 5.0 to 92.0	10.9 Days Interval 1.0 to 77.0

SECONDARY outcome

Timeframe: during hospitalization (after recruitment)

Outcome measures

Measure	Control n=31 Participants Received standard face mask	Total Face Mask n=29 Participants Received Total Face Mask
In-hospital Mortality Rate	6 Participants	3 Participants

Adverse Events

Total Face Mask

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard Face Mask Controls

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Total Face Mask n=29 participants at risk Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls	Standard Face Mask Controls n=31 participants at risk Patients receiving NPPV by 'standard oronasal mask'
Respiratory, thoracic and mediastinal disorders Claustrophobia	20.7% 6/29 • Number of events 6	12.9% 4/31 • Number of events 4

Additional Information

Nicholas Hill MD

Tufts Medical Center

Phone: 617-636-4288

Email: nhill@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place