Clinical trial NCT01234233: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering
Official title: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: hypothermia, accidental
prewarming
body temperature monitoring
preoperative warming
sublingual temperature assessment
tympanic temperature assessment
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.

Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. \< 36°C) and shivering will be assessed postoperatively.

Detailed description: Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.

The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.

The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. \< 36°C) and shivering will be assessed postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for minor surgery (planned duration approximately \<1h).
* Age 18-75yrs,
* ASA I-II physical status

Exclusion Criteria:

* Emergency surgery,
* pregnant patients,
* patients not able to give informed consent,
* duration of surgery \>2h,
* necessary postoperative mechanical ventilation

Primary outcomes:
measure: Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
timeFrame: postoperative arrival at PACU (once)
Secondary outcomes:
measure: Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.
timeFrame: preoperatively (once) at arrival at PACU
measure: Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.
timeFrame: intraoperatively (30 min after start of surgery), once
measure: Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.
timeFrame: at postoperative arrival at PACU, once
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: UK-SH, Campus Kiel
state: Schleswig-Holstein
city: Pinneberg
country: Germany
facility: Klinikum Pinnerberg, Dep. of Anaesthesiology
state: Schleswig-Holstein
Study officials:
affiliation: Dep. of Anaesthesiology, UK-SH, Campus Kiel
name: Markus Steinfath, M.D.
role: STUDY_DIRECTOR
affiliation: Klinikum Pinnerberg, Pinneberg, Germany
name: Ernst P Horn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Anaesthesiology, UK-SH, Campus Kiel
name: Jan Höcker, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Anaesthesiology, UK-SH, Campus Kiel
name: Berthold Bein, M.D.
role: STUDY_CHAIR
References:
citation: Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.