Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Control group - no intervention: no preoperative warming

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 - 10 min prewarming

10 min prewarming preoperatively

Group Type ACTIVE_COMPARATOR

duration of preoperative active warming

Intervention Type PROCEDURE

duration of prewarming by "forced air warming"

Group 3 - 20 min prewarming

20 min prewarming preoperatively

Group Type ACTIVE_COMPARATOR

duration of preoperative active warming

Intervention Type PROCEDURE

duration of prewarming by "forced air warming"

Group 4 - 30 min prewarming

30 min prewarming preoperatively

Group Type ACTIVE_COMPARATOR

duration of preoperative active warming

Intervention Type PROCEDURE

duration of prewarming by "forced air warming"

Interventions

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duration of preoperative active warming

duration of prewarming by "forced air warming"

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes