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

NCT ID: NCT02382133

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Hypotension; Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Nasal alar oxygen sensor

Application of a nasal alar oxygen sensor

Group Type: OTHER

Nasal alar oxygen sensor

Intervention Type: DEVICE

Application of a nasal alar oxygen sensor

Interventions

Nasal alar oxygen sensor

Application of a nasal alar oxygen sensor

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lynn Schallom

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilyn E Schallom, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Barnes-Jewish Hospital at Washington University

Locations

Barnes-Jewish Hospital at Washington University

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29402444 (View on PubMed)

Other Identifiers

201408123

Identifier Type: -

Identifier Source: org_study_id