Trial Outcomes & Findings for A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask (NCT NCT02383719)

Results Overview

With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes. The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

During non-invasive ventilation with the oro-nasal mask

Results posted on

2016-05-16

Participant Flow

Comfort of mask fit for patients receiving non-invasive ventilation at Shands hospital in Gainesville Florida

Participant milestones

Participant milestones
Measure	Oro-nasal Mask Oro-nasal Mask
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oro-nasal Mask n=18 Participants Oro-nasal Mask
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=39 Participants
Sex: Female, Male Female	10 Participants n=39 Participants
Sex: Female, Male Male	8 Participants n=39 Participants
Region of Enrollment United States	18 participants n=39 Participants

PRIMARY outcome

Timeframe: During non-invasive ventilation with the oro-nasal mask

With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes. The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree

Outcome measures

Outcome measures
Measure	Oro-nasal Mask n=18 Participants All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
Clinician Assessment of Use With a Questionnaire Ease of Use	5 units on a scale Interval 4.0 to 5.0
Clinician Assessment of Use With a Questionnaire Patient Comfort	4 units on a scale Interval 4.0 to 5.0

Adverse Events

Oro-nasal Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Coordinator

Convergent Engineering

Phone: 3523784899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place