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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Pressure Ulcer
• Intervention / Treatment: Device: Nasal alar oxygen sensor

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital at Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nasal alar oxygen sensor; Application of a nasal alar oxygen sensor	Device: Nasal alar oxygen sensor; Application of a nasal alar oxygen sensor

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Marilyn E Schallom, RN, PhD, Barnes-Jewish Hospital at Washington University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Hypotension; Pressure Ulcer
• Other Study ID Numbers: 201408123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO