Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Procedure: duration of preoperative active warming

• Registration Number: NCT01234233
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4 - 30 min prewarming	duration of preoperative active warming	30 min prewarming preoperatively
Group 2 - 10 min prewarming	duration of preoperative active warming	10 min prewarming preoperatively
Group 3 - 20 min prewarming	duration of preoperative active warming	20 min prewarming preoperatively

Primary Outcome Measures

Name	Time	Method
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)	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.

Secondary Outcome Measures

Name	Time	Method
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.	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 postoperatively in awake patients.	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.
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.	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.

Trial Locations

Locations (2)

Klinikum Pinnerberg, Dep. of Anaesthesiology; 🇩🇪 Pinneberg, Schleswig-Holstein, Germany

UK-SH, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany