Trial Outcomes & Findings for Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation (NCT NCT02743936)

Results Overview

Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

2 minutes after mask placement

Results posted on

2016-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	NIPPV With Nasal Cannula First Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place. Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation	NIPPV Without Nasal Cannula First Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NIPPV With Nasal Cannula First n=32 Participants Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place. Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation	NIPPV Without Nasal Cannula First n=32 Participants Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation	Total n=64 Participants Total of all reporting groups
Age, Continuous	31 years n=5 Participants	32 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 minutes after mask placement

Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine

Outcome measures

Outcome measures
Measure	NIPPV With Nasal Cannula n=64 Participants Non-invasive positive pressure ventilation with nasal cannula in place Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation	NIPPV Without Nasal Cannula n=64 Participants Non-invasive positive pressure ventilation without nasal cannula Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation
Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine	0 Liters per minute Interval 0.0 to 3.3	0 Liters per minute Interval 0.0 to 0.9

SECONDARY outcome

Timeframe: After study completion (approximately 2 minutes after study start)

Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)

Outcome measures

Outcome measures
Measure	NIPPV With Nasal Cannula n=64 Participants Non-invasive positive pressure ventilation with nasal cannula in place Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation	NIPPV Without Nasal Cannula n=64 Participants Non-invasive positive pressure ventilation without nasal cannula Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation
Patient Discomfort (Verbal Numerical Rating Scale)	3 Scores on verbal numerical rating scale Interval 2.0 to 5.0	1 Scores on verbal numerical rating scale Interval 1.0 to 2.0

Adverse Events

NIPPV With Nasal Cannula First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NIPPV Without Nasal Cannula First

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

Dr. Michael D. April

Brooke Army Medical Center

Phone: 210-916-0808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place