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Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units. In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement. This study compares the accuracy of forehead oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device related pressure ulcers with both.
Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units. In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement. Several studies have demonstrated the utility of forehead sensor measurements under these clinical conditions. Forehead sensor measurement is considered to be a more central measurement than with digit or ear sensors. However the sensor requires a head band for accurate measurement. On a regular basis, the forehead sensor has led to pressure ulcer development at Barnes-Jewish Hospital despite following vendor recommendations for alternating placement every 8 hours from one side of the forehead to the other. An alternate sensor placed on the nose has recently demonstrated rapid detection of induced drops in oxygen saturation. It has also demonstrated correlation with arterial oxygen saturation measured in a clinical laboratory. The oxygen saturation measurement from the nose is also considered a central measurement. However, studies of the nose sensor were conducted in healthy subjects or during anesthesia care over several hours. Therefore, research is needed to examine the accuracy of the nose sensor in the ICU patient population. In addition, due to concerns for sensor related pressure ulcers in patients with decreased perfusion, the sensor needs to be evaluated for extended periods of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal alar oxygen sensor | Other | Application of a nasal alar oxygen sensor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal alar oxygen sensor | Device | Application of a nasal alar oxygen sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation | accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Device Related Pressure Ulcer | assessment for development of pressure ulcer at forehead sensor, "OxiMaxTM, Nellcor,Covidien" and nasal alar sensor, "Alar One-SenseTM, Xhale Assurance" | 5 days |
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Inclusion Criteria:
1. Presence of an existing arterial catheter for blood sampling and one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn E Schallom, RN, PhD | Barnes-Jewish Hospital at Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital at Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29402444 | Derived | Schallom M, Prentice D, Sona C, Arroyo C, Mazuski J. Comparison of nasal and forehead oximetry accuracy and pressure injury in critically ill patients. Heart Lung. 2018 Mar-Apr;47(2):93-99. doi: 10.1016/j.hrtlng.2017.12.002. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Alar Oxygen Sensor | Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Alar Oxygen Sensor | Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation | accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures | Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment. | Posted | Count of Participants | Participants | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Alar Oxygen Sensor | Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor |
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50% the patients expired after being placed on comfort care prior to final collection
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marilyn Schallom | Barnes-Jewish Hospital | 314-286-0835 | marilyn.schallom@bjc.org |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
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| arterial catheter loss |
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| pressure injury both sites |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Device Related Pressure Ulcer | assessment for development of pressure ulcer at forehead sensor, "OxiMaxTM, Nellcor,Covidien" and nasal alar sensor, "Alar One-SenseTM, Xhale Assurance" | incidence of any pressure injury | Posted | Number | participants | 5 days |
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| 22 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
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| D017437 |
| Skin and Connective Tissue Diseases |