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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02382133
• Other study ID #: 201408123
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 10, 2015
• Last updated: March 5, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness
• Hypotension
• Pressure Ulcer

Intervention

Device:
• Nasal alar oxygen sensor
Application of a nasal alar oxygen sensor

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital at Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy as indicated by co-oximetry measure of arterial oxygen saturation	comparison of sensor measures with co-oximetry measures	24 hours	No
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"	5 days	Yes