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

Shivering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157648
• Other study ID #: 581/2557
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2015
• Last updated: May 16, 2017
• Start date: January 2015
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: Mahidol University
• Contact: Pairin Simcharoen, MD.
• Phone: 0875427917
• Email: pairin072[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Postoperative patient at PACU (Post Anesthesia Care Unit)

• Duration of operation from 1 to 4 hours

• The patients American Society of Anesthesiologist classification from I to III

• The patients' age from 18 years old

Exclusion criteria:

• The patients who reject or unwilling to participate

• The patient who was induced hypothermia in intra-operative period

• The patient who still has neuromuscular blocking agent drugs effect in PACU

• The patient with shock or receiving continuous vasopressor drugs

Withdrawal or termination criteria:

• The patient who has intra-operative or immediate post-operative cardiac arrest and/or death

Related Conditions & MeSH terms

• Body Temperature
• Shivering

Intervention

Other:
• observing for shivering symptom
In the PACU investigators measure body temperature of all patients at tympanic membrane, forehead, and dorsal of hand. Investigators calculate the difference between body temperature measure at tympanic membrane and forehead/dorsal of hand. Investigators observe the shivering symptom and grading for severity.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok	Bangkoknoi

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in temperature	Difference in temperature measured at tympanic membrane and forehead	immediate after arriving in PACU
Secondary	Change in temperature	Difference in temperature measured at tympanic membrane and dorsal hand	immediate after arriving in PACU
Secondary	Shivering symptom	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).	immediate after arriving in PACU

External Links

•   Effects of hypothermia and shivering on standard PACU monitoring of patients.
•   Perioperative shivering: physiology and pharmacology.
•   The intensity of postoperative shivering is unrelated to axillary temperature.
•   Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering.