ShiveringNCT03157648
Relationship Between Core-peripheral Temperature Difference and Shivering Symptom in Patients in PACU
An observational study of Shivering and Body Temperature, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shivering, Body Temperature
- What is being tested?
- observing for shivering symptom
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, 10700
pairin Simcharoen, +66875427917, pairin072@gmail.com
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Shivering, Body Temperature
- Being tested
- observing for shivering symptom
- Keywords
- Shivering temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observing for shivering symptomOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in temperature
Difference in temperature measured at tympanic membrane and forehead
Measured: immediate after arriving in PACU
Secondary outcomes (2)
Change in temperature
Difference in temperature measured at tympanic membrane and dorsal hand
Measured: immediate after arriving in PACU
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).
Measured: immediate after arriving in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJan 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuriphong Songarj, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157648
- Sponsor's protocol ID
- 581/2557
- Status last verified
- May 2017
- First submitted
- 6 Jul 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the other researcher required data, please direct contact to principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Core-peripheral Temperature Difference and Shivering Symptom in Patients in PACU
- ClinicalTrials.gov ID
- NCT03157648
- Acronym / sponsor ID
- 581/2557
- Conditions
- Shivering, Body Temperature
- Keywords
- Shivering temperature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- The patient who has intra-operative or immediate post-operative cardiac arrest and/or death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observing for shivering symptomIn 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. | Other | – |
Primary outcome
Difference in temperature
Time frame: immediate after arriving in PACU
Difference in temperature measured at tympanic membrane and forehead
2 secondary outcomes
Change in temperature
Time frame: immediate after arriving in PACU
Shivering symptom
Time frame: immediate after arriving in PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering.Link provided by the sponsor.
- Effects of hypothermia and shivering on standard PACU monitoring of patients.Link provided by the sponsor.
- Perioperative shivering: physiology and pharmacology.Link provided by the sponsor.
- The intensity of postoperative shivering is unrelated to axillary temperature.Link provided by the sponsor.
- Individual participant dataSharing planned: No. When the other researcher required data, please direct contact to principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuriphong Songarj, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shivering and Body Temperature, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pairin Simcharoen, MD. (0875427917, pairin072@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in temperature (time frame: immediate after arriving in PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.