Trial Outcomes & Findings for In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency (NCT NCT01347931)
NCT ID: NCT01347931
Last Updated: 2016-10-11
Results Overview
Time in minutes of sustained activity while using test treatments
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Measured during single day study visit
Results posted on
2016-10-11
Participant Flow
Participant milestones
| Measure |
Standard Oxygen Therapy
Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
|---|---|
|
Standard Oxygen Therapy
STARTED
|
30
|
|
Standard Oxygen Therapy
COMPLETED
|
29
|
|
Standard Oxygen Therapy
NOT COMPLETED
|
1
|
|
NIOV System
STARTED
|
29
|
|
NIOV System
COMPLETED
|
29
|
|
NIOV System
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Standard Oxygen Therapy
Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
|---|---|
|
Standard Oxygen Therapy
Withdrawal by Subject
|
1
|
Baseline Characteristics
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
Baseline characteristics by cohort
| Measure |
Overall Study Group
n=30 Participants
All subjects participating in 2-way crossover design study
|
|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured during single day study visitPopulation: Per Protocol
Time in minutes of sustained activity while using test treatments
Outcome measures
| Measure |
Standard Oxygen Therapy
n=29 Participants
Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
Breathe NIOV System
n=29 Participants
Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
|---|---|---|
|
Activity Endurance Time
|
7.24 minutes
Standard Deviation 5.21
|
13.38 minutes
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Measured during activity testing in a single day study visitPopulation: Per Protocol
O2 saturation measured by pulse oximetry
Outcome measures
| Measure |
Standard Oxygen Therapy
n=29 Participants
Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
Breathe NIOV System
n=29 Participants
Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
|---|---|---|
|
Arterial Oxygen Saturation
|
90.65 percentage of oxyHb saturation
Standard Deviation 4.87
|
94.78 percentage of oxyHb saturation
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Measured during activity testing in a single day study visitPopulation: Per Protocol
Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome
Outcome measures
| Measure |
Standard Oxygen Therapy
n=29 Participants
Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
Breathe NIOV System
n=29 Participants
Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
|
|---|---|---|
|
Borg Dyspnea Score
|
3 units on a scale
Interval 2.8 to 4.07
|
1 units on a scale
Interval 1.0 to 2.4
|
Adverse Events
Standard Oxygen Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breathe NIOV System
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
Richard J. Morishige, MS, RRT
Clinical Reseach Consulting
Phone: 510-606-0375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place