Trial Outcomes & Findings for Using Capnography to Reduce Hypoxia During Pediatric Sedation (NCT NCT01463527)
NCT ID: NCT01463527
Last Updated: 2018-01-11
Results Overview
These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)
Results posted on
2018-01-11
Participant Flow
Participant milestones
| Measure |
Open Capnography
Staff members able to view capnography monitor during sedation.
|
Capnography Blind
Staff members blinded to capnography screen and alarms turned off during sedation.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
|
Overall Study
COMPLETED
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Open Capnography
Staff members able to view capnography monitor during sedation.
|
Capnography Blind
Staff members blinded to capnography screen and alarms turned off during sedation.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Crying >20% of sedation
|
5
|
6
|
Baseline Characteristics
Using Capnography to Reduce Hypoxia During Pediatric Sedation
Baseline characteristics by cohort
| Measure |
Open Capnography
n=77 Participants
Staff members able to view capnography monitor during sedation.
|
Capnography Blind
n=77 Participants
Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.6 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
8.2 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
8.4 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Indication for sedation
Fracture reduction
|
43 participants
n=99 Participants
|
42 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Indication for sedation
Laceration repair
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Indication for sedation
Incision and drainage of abscess
|
16 participants
n=99 Participants
|
12 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Indication for sedation
Arthorcentesis
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Indication for sedation
Dislocation
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Indication for sedation
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Weight
|
35.8 kg
STANDARD_DEVIATION 20.8 • n=99 Participants
|
35.8 kg
STANDARD_DEVIATION 21.8 • n=107 Participants
|
35.8 kg
STANDARD_DEVIATION 21.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.
Outcome measures
| Measure |
Open Capnography
n=77 Participants
Staff able to view capnography monitor during sedation.
|
Capnography Blind
n=77 Participants
Staff blinded to capnography screen and alarms turned off during sedation.
|
|---|---|---|
|
Frequency of Staff Interventions for Hypoventilation.
|
0.39 Events per patient minute of sedation
Interval 0.0 to 2.084
|
0.396 Events per patient minute of sedation
Interval 0.0 to 2.03
|
SECONDARY outcome
Timeframe: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)While there were 77 patients per group, each patient had vital signs measured every 30 seconds for the duration of their stay. This resulted in a variable amount of time points (data points) recorded per patient. Our event frequency was the number of events (outcome measure of abnormal vital signs) per number of time points for each patient. This is presented as an event rate.
Outcome measures
| Measure |
Open Capnography
n=4330 Total Number of Time Points per Group
Staff able to view capnography monitor during sedation.
|
Capnography Blind
n=4264 Total Number of Time Points per Group
Staff blinded to capnography screen and alarms turned off during sedation.
|
|---|---|---|
|
Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.
|
0.024 rate of total events/total time points
Interval 0.0 to 0.4
|
0.016 rate of total events/total time points
Interval 0.0 to 0.176
|
Adverse Events
Open Capnography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Capnography Blind
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