Clinical trial NCT02382133: Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
Official title: Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Pressure Ulcer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation
timeFrame: 24 hours
Secondary outcomes:
measure: Device Related Pressure Ulcer
timeFrame: 5 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital at Washington University
state: Missouri
Study officials:
affiliation: Barnes-Jewish Hospital at Washington University
name: Marilyn E Schallom, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.