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

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Completed

CT.gov ID

NCT01234233

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

200

Patients Per Site

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Procedure: duration of preoperative active warming	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

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

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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UK-SH, Campus Kiel	Kiel	Schleswig-Holstein	Germany	24105
2	Klinikum Pinnerberg, Dep. of Anaesthesiology	Pinneberg	Schleswig-Holstein	Germany	25421

Sponsors and Collaborators

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