Expired Study
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St. Louis, Missouri 63110


Purpose:

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 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. 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.


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


Study is Available At:


Original ID:

201408123


NCT ID:

NCT02382133


Secondary ID:


Study Acronym:


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


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Marilyn E Schallom, RN, PhD
Principal Investigator
Barnes-Jewish Hospital at Washington University

Study Dates

Start Date:October 2014
Completion Date:January 2016
Completion Type:Anticipated
Primary Completion Date:December 2015
Primary Completion Type:Anticipated
Verification Date:March 2015
Last Changed Date:March 5, 2015
First Received Date:February 10, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:device related pressure ulcer
Time Frame:5 days
Safety Issues:True
Description:assessment for development of pressure ulcer at forehead sensor, "OxiMaxTM, Nellcor,Covidien" and nasal alar sensor, "Alar One-SenseTM, Xhale Assurance"
Outcome Type:Primary Outcome
Measure:accuracy as indicated by co-oximetry measure of arterial oxygen saturation
Time Frame:24 hours
Safety Issues:False
Description:comparison of sensor measures with co-oximetry measures

Study Interventions

Intervention Type:Device
Name:Nasal alar oxygen sensor
Description:Application of a nasal alar oxygen sensor
Arm Name:Nasal alar oxygen sensor

Study Arms

Study Arm Type:No Intervention
Arm Name:Nasal alar oxygen sensor
Description:Application of a nasal alar oxygen sensor

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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