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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jan Hoecker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01234233
First received: September 9, 2010
Last updated: October 10, 2011
Last verified: October 2011
History of Changes

September 9, 2010
October 10, 2011
March 2010
March 2011   (final data collection date for primary outcome measure)
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) [ Time Frame: postoperative arrival at PACU (once) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01234233 on ClinicalTrials.gov Archive Site
  • Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. [ Time Frame: preoperatively (once) at arrival at PACU ] [ Designated as safety issue: No ]
    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.
  • Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients. [ Time Frame: intraoperatively (30 min after start of surgery), once ] [ Designated as safety issue: No ]
    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.
  • Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients. [ Time Frame: at postoperative arrival at PACU, once ] [ Designated as safety issue: No ]
    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.
  • Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. [ Time Frame: preoperatively (once) at arrival at PACU ] [ Designated as safety issue: No ]
    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.
  • Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients. [ Time Frame: intraoperatively (start of surgery), once ] [ Designated as safety issue: No ]
    Sublingual and tympanic body temperature will be assessed simultaneously (once) at 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 at start of surgery.Afterwards patients will be observed for about 3h.
  • Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients. [ Time Frame: at postoperative arrival at PACU, once ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypothermia
Procedure: duration of preoperative active warming
duration of prewarming by "forced air warming"
  • No Intervention: Group 1
    Control group - no intervention: no preoperative warming
    Intervention: Procedure: duration of preoperative active warming
  • Active Comparator: Group 2 - 10 min prewarming
    10 min prewarming preoperatively
    Intervention: Procedure: duration of preoperative active warming
  • Active Comparator: Group 3 - 20 min prewarming
    20 min prewarming preoperatively
    Intervention: Procedure: duration of preoperative active warming
  • Active Comparator: Group 4 - 30 min prewarming
    30 min prewarming preoperatively
    Intervention: Procedure: duration of preoperative active warming
Höcker J, Bein B, Böhm 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
May 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01234233
THER-JH
No
Dr. Jan Hoecker, University of Schleswig-Holstein
University of Schleswig-Holstein
Not Provided
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
University of Schleswig-Holstein
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP