Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Capnography | Experimental |
| |
| Capnography Blind | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nellcor NPB-70 Capnograph | Device | Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa Langhan, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Children's Hospital | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25445871 | Derived | Langhan ML, Shabanova V, Li FY, Bernstein SL, Shapiro ED. A randomized controlled trial of capnography during sedation in a pediatric emergency setting. Am J Emerg Med. 2015 Jan;33(1):25-30. doi: 10.1016/j.ajem.2014.09.050. Epub 2014 Oct 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open Capnography | Staff members able to view capnography monitor during sedation. |
| FG001 | Capnography Blind | Staff members blinded to capnography screen and alarms turned off during sedation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Capnography | Staff members able to view capnography monitor during sedation. |
| BG001 | Capnography Blind | Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | Events per patient minute of sedation | Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) |
|
During time of sedation in emergency department, an average of 36 minutes
No serious adverse events were recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Capnography | Nellcor 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 |
Not provided
Not provided
No serious adverse events were recorded. Since these events are rare and this study was not powered to detect them, we are unable to predict how capnography may have impacted staff behavior and patient outcomes for these less frequent events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Langhan | Yale University | 203-737-7413 | melissa.langhan@yale.edu |
Not provided
| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Indication for sedation | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Full Range | rate of total events/total time points | Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) | Total Number of Time Points per Group | Total Number of Time Points per Group |
|
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Capnography Blind | Nellcor 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 | 0 | 77 | 0 | 77 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |