Hypoventilation, Hypoxia
Conditions
Keywords
Hypoventilation during sedation, Hypoxia associated with hypoventilation
Brief summary
The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.
Interventions
DEVICENellcor NPB-70 Capnograph
Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital
Exclusion criteria
* Unable to tolerate nasal-oral cannula * Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma) * Intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Staff Interventions for Hypoventilation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Capnography Staff members able to view capnography monitor during sedation. | 77 |
| Capnography Blind Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation. | 77 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Crying >20% of sedation | 5 | 6 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Capnography Blind | Open Capnography |
|---|---|---|---|
| Age, Continuous | 8.4 years STANDARD_DEVIATION 5 | 8.2 years STANDARD_DEVIATION 4.8 | 8.6 years STANDARD_DEVIATION 5.1 |
| Indication for sedation Arthorcentesis | 5 participants | 3 participants | 2 participants |
| Indication for sedation Dislocation | 5 participants | 4 participants | 1 participants |
| Indication for sedation Fracture reduction | 85 participants | 42 participants | 43 participants |
| Indication for sedation Incision and drainage of abscess | 28 participants | 12 participants | 16 participants |
| Indication for sedation Laceration repair | 29 participants | 16 participants | 13 participants |
| Indication for sedation Other | 2 participants | 0 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 13 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 119 Participants | 60 Participants | 59 Participants |
| Sex: Female, Male Female | 65 Participants | 34 Participants | 31 Participants |
| Sex: Female, Male Male | 89 Participants | 43 Participants | 46 Participants |
| Weight | 35.8 kg STANDARD_DEVIATION 21.3 | 35.8 kg STANDARD_DEVIATION 21.8 | 35.8 kg STANDARD_DEVIATION 20.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Frequency of Staff Interventions for Hypoventilation.
These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.
Time frame: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Capnography | Frequency of Staff Interventions for Hypoventilation. | 0.39 Events per patient minute of sedation |
| Capnography Blind | Frequency of Staff Interventions for Hypoventilation. | 0.396 Events per patient minute of sedation |
Comparison: Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.95% CI: [0.17, 0.57]
Secondary
Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.
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.
Time frame: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Capnography | Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. | 0.024 rate of total events/total time points |
| Capnography Blind | Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. | 0.016 rate of total events/total time points |
p-value: 0.3GEE (Generalized Estimating Equation)