Clinical Trial: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.

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 Summary:

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.


Sponsor: University of Schleswig-Holstein

Current Primary Outcome: Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) [ Time Frame: postoperative arrival at PACU (once) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. [ Time Frame: preoperatively (once) at arrival at PACU ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. [ Time Frame: preoperatively (once) at arrival at PACU ]
    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 ]
    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 ]
    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.


Information By: University of Schleswig-Holstein

Dates:
Date Received: September 9, 2010
Date Started: March 2010
Date Completion:
Last Updated: May 12, 2016
Last Verified: May 2016