Relationship Between Core-peripheral Temperature Difference and Shivering Symptom in Patients in PACU

• Conditions: Shivering; Body Temperature

• Registration Number: NCT03157648
• Lead Sponsor: Mahidol University

Brief Summary

Shivering is a physiologic response to early hypothermia in mammals. The definition of shivering is an involuntary, oscillatory muscular activity that augments metabolic heat production.

Routinely in post anesthetic care unit (PACU), the core temperature via tympanic membrane is always measured in all patients. Sometimes patients who have low temperature have no shivering symptom in other hand patients who have normal temperature have shivering symptom. This indicates that, only core temperature is not enough for predicting or detecting patients who will have shivering symptom in PACU.

In this study, investigators hypothesise that the core-peripheral temperature difference in postoperative period indicates patients who will have shivering symptom.

Thus, the aims of this study are to evaluate the relationship between core-peripheral temperature difference and shivering symptom in patients in PACU.

Detailed Description

Humans are warm-blooded animal or homeotherms. They are able to regulate their body temperature which in physiologic range themselves. The body temperature is controlled by balancing heat production and heat loss. The normal body temperature refers to either core temperature (eg. tympanic membrane, esophagus, and intra-urinary bladder) or peripheral temperature (eg. skin, forehead, and axillar). Core temperature is the temperature of the deep tissues of the body. The normal range of core temperature is between 36.5-37.5 degree celsius. The peripheral temperature, in contrast to the core temperature, can be changed by many factors such as the temperature of the surroundings environment.

The term of hypothermia is the core temperature less than or equal to 36.4 degree celsius. When the body exposes to cold temperature, heat loss is decreased and heat production is increased as defense mechanism for keeping balance in several means: stop sweating, piloerection, cutaneous arterioles constriction, shivering, which increases heat production in skeletal muscles, conversion from fat to energy by mitochondria.Hypothermia is one of factors, which relates to postoperative complications.

Shivering is an oscillatory muscular activity that augments metabolic heat production. Vigorous shivering increases metabolic heat production up to 600% above basal level. Shivering is a common postoperative period complication. The pathophysiology of postoperative shivering remains unclear otherwise various mechanisms have been proposed. Shivering may happen as a thermoregulatory response to hypothermia or muscle hyperactivity with clonic or tonic patterns. Although cold-induced shivering is an obvious source of postanesthetic tremor. Some of the patients who suffer from shivering are believed to be nonthermoregulatory because their core temperatures remain normal. The incidence of postoperative shivering is 65% of patients after general anesthesia and 33% of patients after regional anesthesia.

This is the prospective observation clinical study. Investigators will observe shivering symptom and measure the patients' temperature at tympanic membrane, forehead, and dorsal of hand at many time points.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-07-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in temperature	immediate after arriving in PACU	Difference in temperature measured at tympanic membrane and forehead

Secondary Outcome Measures

Name	Time	Method
Change in temperature	immediate after arriving in PACU	Difference in temperature measured at tympanic membrane and dorsal hand
Shivering symptom	immediate after arriving in PACU	Severity of shivering symptom from 0 to 4 grade (0 = No shivering, 1 = No visible muscle activity, but one or more of piloerection, peripheral vasoconstriction or peripheral cyanosis, 2 = Muscular activity in only one muscle group, 3 = Moderate muscular activity in more than one muscle group, but not generalized shaking, 4 = Violent muscular activity that involves the entire body).

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Bangkoknoi, Thailand