Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering (THER4-1)

Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Procedure: duration of preoperative active warming

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • UK-SH, Campus Kiel
    • Pinneberg, Schleswig-Holstein, Germany, 25421
      • Klinikum Pinnerberg, Dep. of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; Control group - no intervention: no preoperative warming
Active Comparator: Group 2 - 10 min prewarming; 10 min prewarming preoperatively	Procedure: duration of preoperative active warming; duration of prewarming by "forced air warming"
Active Comparator: Group 3 - 20 min prewarming; 20 min prewarming preoperatively	Procedure: duration of preoperative active warming; duration of prewarming by "forced air warming"
Active Comparator: Group 4 - 30 min prewarming; 30 min prewarming preoperatively	Procedure: duration of preoperative active warming; duration of prewarming by "forced air warming"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)	After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.	postoperative arrival at PACU (once)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.	Sublingual and tympanic body temperature will be assessed simultaneously once at patients' preoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for assessment of data: one single measurement immediately (1 min) after patients' arrival at PACU. Afterwards: observation of patients for about 2h.	preoperatively (once) at arrival at PACU
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.	Sublingual and tympanic body temperature will be assessed simultaneously (once) 30 min after start of surgery and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 1 min after 30 min after start of surgery.Afterwards patients will be observed for about 3h.	intraoperatively (30 min after start of surgery), once
Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.	Sublingual and tympanic body temperature will be assessed simultaneously (once) at patients' postoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 30 sec immediately after patients' arrival at PACU.	at postoperative arrival at PACU, once

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Study Director: Markus Steinfath, M.D., Dep. of Anaesthesiology, UK-SH, Campus Kiel; Principal Investigator: Ernst P Horn, M.D., Klinikum Pinnerberg, Pinneberg, Germany; Principal Investigator: Jan Höcker, M.D., Dep. of Anaesthesiology, UK-SH, Campus Kiel; Study Chair: Berthold Bein, M.D., Dep. of Anaesthesiology, UK-SH, Campus Kiel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: prewarming; preoperative warming; hypothermia, accidental; body temperature monitoring; sublingual temperature assessment; tympanic temperature assessment
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: THER-JH