Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
Primary Purpose
Hypotension, Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal alar oxygen sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypotension
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
Sites / Locations
- Barnes-Jewish Hospital at Washington University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nasal alar oxygen sensor
Arm Description
Application of a nasal alar oxygen sensor
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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"
Full Information
NCT ID
NCT02382133
First Posted
February 10, 2015
Last Updated
May 8, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02382133
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Pressure Ulcer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal alar oxygen sensor
Arm Type
Other
Arm Description
Application of a nasal alar oxygen sensor
Intervention Type
Device
Intervention Name(s)
Nasal alar oxygen sensor
Intervention Description
Application of a nasal alar oxygen sensor
Primary Outcome Measure Information:
Title
Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation
Description
accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Device Related Pressure Ulcer
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn E Schallom, RN, PhD
Organizational Affiliation
Barnes-Jewish Hospital at Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital at Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29402444
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.
Results Reference
derived
Learn more about this trial
Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
We'll reach out to this number within 24 hrs