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

NCT03157648 | Unknown DMC

• 1 other identifier: 581/2557
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Shivering; Body Temperature

Keywords

Shivering temperature

Outcome Measures

Primary Outcomes (1)

• Difference in temperature

  Difference in temperature measured at tympanic membrane and forehead

  immediate after arriving in PACU

Secondary Outcomes (2)

• Change in temperature

  immediate after arriving in PACU

• Shivering symptom

  immediate after arriving in PACU

Interventions

observing for shivering symptom OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are in the Siriraj PACU at 5th floor Siammintr building. The patients are one of the patients from head-neck-breast surgery, general surgery, or urology surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkoknoi, 10700, Thailand

RECRUITING

Related Links

• Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering.
• 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.

Study Officials

• Phuriphong Songarj, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pairin Simcharoen, MD.

CONTACT

0875427917; pairin072@gmail.com

Songarj, MD

CONTACT

0897039553; aeh_118@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: May 17, 2017
• Study Start: January 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)