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Research Protocol Thermometer For IRB Revision
Research Protocol Thermometer For IRB Revision
DEPARTMENT OF PEDIATRICS
Advisers:
Tricia B. Santos, M.D., DPPS
James L. Angtuaco, M.D., DPPS, DPSPC, FPCC
2017
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
ABSTRACT
CONTEXT
OBJECTIVE
DESIGN
PARTICIPANTS
RESULTS
CONCLUSIONS
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
GLOSSARY OF ABBREVIATIONS
CHAPTER I
INTRODUCTION
BACKGROUND
Body temperature is one of the most important vital signs in
pediatric. During investigation and diagnosis of patients, accurate
(1)
temperature measurement is of great importance . Measurement of body
temperature is one of the oldest known diagnostic methods and still
remains an important indicator of health and disease, both in everyday life
and in medical care (2).
An ideal thermometer should: accurately reflect the core body
temperature in all age groups; be convenient, easy and comfortable to
use; give rapid results; not cause cross infection among patients; not be
influenced by room temperature; and be safe and cost effective. 3–4 In
practice, every available method has several advantages and
disadvantages.4
The best sites for measuring body temperature are those closest to
the hypothalamus, the temperature regulating center that reflects the
“core” temperature.5 Since the hypothalamus is inaccessible, the core
temperature is generally defined as the temperature measured within the
pulmonary artery.6 Other alternative sites which have been used, including
distal esophagus, bladder, and nasopharynx, are accurate within 0.1-
0.2°C of core temperature.7
However, since these sites are clinically inaccessible, clinicians
have utilized the rectum as a practical site that most closely reflects core
temperature.7 Unfortunately, rectal thermometry has been resented by
many children and their parents 8, leaving axillary thermometry as the only
option in many cases.
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
DEFINITION OF TERMS
Body core Temperature; is the temperature of the vital organs
inside the head and trunk which, together with a variable amount of
other tissue, comprise the warm internal core. should be
determined at a site where the measurement is not biased by
environmental temperature. Clinically used sites include the rectum,
the mouth and, occasionally, the axilla.
Fever is defined as a body temperature ≥38°C (100.4°F), and a
value >40°C (104°F) is called hyperpyrexia.
Body temperature is defined as the average temperature of human
body. fluctuates in a defined normal range (36.6-37.9°C [97.9-
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
b. Gender
c. Prevalence of Fever based on NCIT detection
2. What is the diagnostic accuracy of non-contact infrared
thermometer in measuring the body temperature among pediatric
patient, in terms of:
a. Sensitivity
b. Specificity
c. Positive Predictive Value (PPV)
d. Negative Predictive Value (NPV)
3. What is the diagnostic accuracy of non-contact infrared
thermometer when grouped according to age:
a. Toddler (ages 1–3 years)
b. preschooler (ages 4–6 years)
c. school-aged child (ages 6–13 years)
d. adolescent (ages 13–19)
4. What is the effectiveness of a non-contact infrared thermometer in
measuring body temperature in comparison with the standard
axillary thermometer among pediatric patient, as a whole and per
age group?
Specific Objectives
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
HYPOTHESIS
CHAPTER 2
REVIEW OF RELATED LITERATURE
CHAPTER 3
RESEARCH METHODOLOGY
PARTICIPANTS
The research will take place in Outpatient department of Metropolitan
Medical Center (MMC), a private hospital in Manila, Philippines. All
pediatric patients who came for consult at outpatient department MMC
from August-September 2017 will participate in this study.
POPULATION
• Inclusion criteria:
– Sample will be collected from outpatient department in a
private hospital
– Children aged 1-18 year old
– Male and female children
– Informed consent from parent or guardian of the children
• Exclusion criteria:
– Patients who need immediate care/consult
– Children without informed consent from parent or guardian
STUDY DESIGN
This is an analytic cross-sectional study of pediatric patients form
the OPD, MMC from age 1 to 18 years old where the body temperature
was measured that compares the non-contact infrared thermometer’s
classification of pediatric body temperature with a reference axillary digital
thermometer’s classification.
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
PROCEDURE
Before performing the measurements, the participants are asked if
they consumed hot or cold food or drinks within the last half an hour, if not
smoke, not sweating, not exercise, no head compress and sat in constant
room temperature (27-28oc). Calibrate the thermometers every time before
using the instruments. These instruments will hold at room temperature for
at least 10 min,
Sample will be collected in pediatric patients who consulted in
outpatient department of a private hospital in Manila. The parent or
guardian will sign the informed consent. Measure the room temperature
first, with standard room-temperature setting (27-28°c), at the same time
patient will be measured their temperature simultaneously on two site by
trained nurse;
1. Digital Axillary Thermometer: Dry axillary area, place digital
thermometer under the right arm. Read after the signal tone
heard and record.
2. Non-Contact Infrared Thermometer: Push the hair aside, wipe
the sweat, then hold non-contact infrared thermometer at
distance of 3-5 cm from the midpoint of forehead area until the
signal tone was heard (an average of 1–2 s), read and record.
All result will be document with initial name of patient on the table.
Date/Time Initial Age Gender DAT NCIT Signature
name
INSTRUMENTS
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DEPARTMENT OF PEDIATRICS
STATISTICAL ANALYSIS
All data are encoded in Microsoft Excel and processed using SPSS
Version 23 (IBM Corporation, USA). Diagnostic accuracy, such as
sensitivity, specificity, positive (PPV) and negative predictive values (NPV)
will be calculated to determine the diagnostic accuracy of non-contact
infrared thermometer against the gold standard digital axillary
thermometer. Sensitivity is calculated as the proportion of children who
have fever at 37.8oC and above, who are correctly identified by non-
contact infrared thermometer. Specificity, in turn, is the proportion of
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
REFERENCES
METROPOLITAN MEDICAL CENTER
DEPARTMENT OF PEDIATRICS
20. Gisolfi CV, Mora F. The Hot Brain: Survival, Temperature and the
Human Body. Massachusetts: MIT Press, 2000:1-13, 94-119, 157-
63,171-4, 191-215.
21. Folk GE, Riedesel ML, Thrift DL. Principles of Integrative
Environmental Physiology. Iowa: Austin and Winfield Publishers,
1998.
22. Ilsley AH, Rutten AJ, Runciman WB. An evaluation of body
temperature measurement. Anesth Intensive Care 1983;11:31-9.
23. Haddock BJ, Merow DL, Swanson MS. The falling grace of axillary
temperature. Pediatr Nurs 1996;22:121-5.
24. Karesh MJ. Axillary temperature as a screening test for fever in
children.J Pediatr 1984;104:596-9.
25. Amoateng-Adjepong Y, Del Mundo J, Manthous CA. Accuracy of
an infrared tympanic thermometer. Chest 1999;115:1002-5.