Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion

Study Overview
=================
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.

Official Title
-----------------
Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion

Conditions
-----------------
Hypotension, Pressure Ulcer

Intervention / Treatment
-----------------
* Device: Nasal alar oxygen sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Presence of an existing arterial catheter for blood sampling and one of the following: Difficulty obtaining a consistent signal from a digit or ear sensor or On pressors of at least 0 .10 mcg/kg/min of norepinephrine or Core temperature < or equal to 35 degrees C Exclusion Criteria: Anatomic impediments (burns, wounds, dressings, etc.) to placement of the sensor on the forehead or nasal alar History of known dyshemoglobinemias evidenced by carboxyhemoglobin levels > 10% or methemoglobin level > 2% Severe anemia with hemoglobin < 5 g/dL Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nasal alar oxygen sensor<br>Application of a nasal alar oxygen sensor | Device: Nasal alar oxygen sensor<br>* Application of a nasal alar oxygen sensor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |