Trial Outcomes & Findings for Efficacy Study of a Facemask Device to Treat Hypotension (NCT NCT00256724)
NCT ID: NCT00256724
Last Updated: 2013-07-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
every 2 minutes during 10 minutes of device use
Results posted on
2013-07-31
Participant Flow
Patients were recruited from the emergency department based on age (18-85)and systolic blood pressure ≤95mmHg who were conscious and presumed to have hypotension due to hypoivolemia or relative hypovolemia (blood loss, dehydration, or sepsis).
Participant milestones
| Measure |
Sham ITD
sham Impedance Threshold Device
|
Active ITD
active impedance threshold device
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Sham ITD
sham Impedance Threshold Device
|
Active ITD
active impedance threshold device
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
5
|
|
Overall Study
Protocol Violation
|
3
|
3
|
Baseline Characteristics
Efficacy Study of a Facemask Device to Treat Hypotension
Baseline characteristics by cohort
| Measure |
Sham ITD
n=23 Participants
sham Impedance Threshold Device
|
Active ITD
n=24 Participants
active impedance threshold device
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age Continuous
|
51.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 17.3 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 2 minutes during 10 minutes of device useOutcome measures
| Measure |
Sham ITD
n=18 Participants
sham Impedance Threshold Device
|
Active ITD
n=16 Participants
active impedance threshold device
|
|---|---|---|
|
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
|
5.9 mm Hg
Standard Deviation 5.9
|
12.9 mm Hg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: during 10 minutes of device useOutcome measures
| Measure |
Sham ITD
n=18 Participants
sham Impedance Threshold Device
|
Active ITD
n=16 Participants
active impedance threshold device
|
|---|---|---|
|
Quantity of Fluid Administration
|
175 mL
Standard Deviation 197
|
93 mL
Standard Deviation 170
|
Adverse Events
Sham ITD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active ITD
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place