Hypotension, Pressure Ulcer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENasal alar oxygen sensor
Application of a nasal alar oxygen sensor
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1\. Presence of an existing arterial catheter for blood sampling and one of the following: 1. Difficulty obtaining a consistent signal from a digit or ear sensor or 2. On pressors of at least 0 .10 mcg/kg/min of norepinephrine or 3. Core temperature \< or equal to 35 degrees C
Exclusion criteria
1. Anatomic impediments (burns, wounds, dressings, etc.) to placement of the sensor on the forehead or nasal alar 2. History of known dyshemoglobinemias evidenced by carboxyhemoglobin levels \> 10% or methemoglobin level \> 2% 3. Severe anemia with hemoglobin \< 5 g/dL 4. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation | 24 hours | accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Related Pressure Ulcer | 5 days | assessment for development of pressure ulcer at forehead sensor, OxiMaxTM, Nellcor,Covidien and nasal alar sensor, Alar One-SenseTM, Xhale Assurance |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Alar Oxygen Sensor Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | arterial catheter loss | 4 |
| Overall Study | Death | 22 |
| Overall Study | Physician Decision | 2 |
| Overall Study | pressure injury both sites | 1 |
| Overall Study | transfer out of ICU | 4 |
Baseline characteristics
| Characteristic | Nasal Alar Oxygen Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment United States | 43 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
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
Time frame: 24 hours
Population: Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Alar Oxygen Sensor | Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation | 43 Participants |
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
Time frame: 5 days
Population: incidence of any pressure injury
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal Alar Oxygen Sensor | Device Related Pressure Ulcer | 2 participants |
p-value: =0.006Chi-squared