Trial Outcomes & Findings for Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects (NCT NCT01477450)
NCT ID: NCT01477450
Last Updated: 2014-09-26
Results Overview
Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
50 minutes
Results posted on
2014-09-26
Participant Flow
Participant milestones
| Measure |
1 L/Min ; 16 mL
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
2 L/Min ; 32 mL
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
3 L/Min ; 48 mL
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Baseline characteristics by cohort
| Measure |
1 L/Min ; 16 mL
n=10 Participants
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
2 L/Min ; 32 mL
n=10 Participants
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
3 L/Min ; 48 mL
n=10 Participants
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-65 years
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 50 minutesOxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.
Outcome measures
| Measure |
1 L/Min ; 16 mL
n=10 Participants
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
2 L/Min ; 32 mL
n=10 Participants
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
3 L/Min ; 48 mL
n=10 Participants
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder
|
|---|---|---|---|
|
Return of Oxygen Saturation to Baseline (Sea Level) Values
Reversal of hypoxemia after pulse-dose oxygen
|
6 participants
|
8 participants
|
10 participants
|
|
Return of Oxygen Saturation to Baseline (Sea Level) Values
Non-reversal of hypoxemia after pulse-dose oxygen
|
4 participants
|
2 participants
|
0 participants
|
|
Return of Oxygen Saturation to Baseline (Sea Level) Values
Reversal of hypoxemia after cylinder O2 delivery
|
9 participants
|
10 participants
|
10 participants
|
|
Return of Oxygen Saturation to Baseline (Sea Level) Values
Non-reversal of hypoxemia after cylinder O2 delive
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
1 L/Min ; 16 mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 L/Min ; 32 mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 L/Min ; 48 mL
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