Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

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

Sponsors

Lead Sponsor: University of Schleswig-Holstein

Source University of 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.

Overall Status Completed
Start Date March 2010
Completion Date May 2011
Primary Completion Date March 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) postoperative arrival at PACU (once)
Secondary Outcome
Measure Time Frame
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. preoperatively (once) at arrival at PACU
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients. intraoperatively (30 min after start of surgery), once
Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients. at postoperative arrival at PACU, once
Enrollment 400
Condition
Intervention

Intervention Type: Procedure

Intervention Name: duration of preoperative active warming

Description: duration of prewarming by "forced air warming"

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
UK-SH, Campus Kiel | Kiel, Schleswig-Holstein, 24105, Germany
Klinikum Pinnerberg, Dep. of Anaesthesiology | Pinneberg, Schleswig-Holstein, 25421, Germany
Location Countries

Germany

Verification Date

May 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Schleswig-Holstein

Investigator Full Name: PD Dr. Jan Hoecker

Investigator Title: PD Dr. Jan Höcker

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Group 1

Type: No Intervention

Description: Control group - no intervention: no preoperative warming

Label: Group 2 - 10 min prewarming

Type: Active Comparator

Description: 10 min prewarming preoperatively

Label: Group 3 - 20 min prewarming

Type: Active Comparator

Description: 20 min prewarming preoperatively

Label: Group 4 - 30 min prewarming

Type: Active Comparator

Description: 30 min prewarming preoperatively

Acronym THER4-1
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov