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

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
duration of preoperative active warming
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring hypothermia, accidental, prewarming, body temperature monitoring, preoperative warming, sublingual temperature assessment, tympanic temperature assessment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UK-SH, Campus Kiel
  • Klinikum Pinnerberg, Dep. of Anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2 - 10 min prewarming

Group 3 - 20 min prewarming

Group 4 - 30 min prewarming

Arm Description

Control group - no intervention: no preoperative warming

10 min prewarming preoperatively

20 min prewarming preoperatively

30 min prewarming preoperatively

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 9, 2010
Last Updated
May 12, 2016
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01234233
Brief Title
Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering
Acronym
THER4-1
Official Title
Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
hypothermia, accidental, prewarming, body temperature monitoring, preoperative warming, sublingual temperature assessment, tympanic temperature assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Control group - no intervention: no preoperative warming
Arm Title
Group 2 - 10 min prewarming
Arm Type
Active Comparator
Arm Description
10 min prewarming preoperatively
Arm Title
Group 3 - 20 min prewarming
Arm Type
Active Comparator
Arm Description
20 min prewarming preoperatively
Arm Title
Group 4 - 30 min prewarming
Arm Type
Active Comparator
Arm Description
30 min prewarming preoperatively
Intervention Type
Procedure
Intervention Name(s)
duration of preoperative active warming
Intervention Description
duration of prewarming by "forced air warming"
Primary Outcome Measure Information:
Title
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
Description
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.
Time Frame
postoperative arrival at PACU (once)
Secondary Outcome Measure Information:
Title
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.
Description
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.
Time Frame
preoperatively (once) at arrival at PACU
Title
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.
Description
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.
Time Frame
intraoperatively (30 min after start of surgery), once
Title
Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.
Description
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.
Time Frame
at postoperative arrival at PACU, once

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Steinfath, M.D.
Organizational Affiliation
Dep. of Anaesthesiology, UK-SH, Campus Kiel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ernst P Horn, M.D.
Organizational Affiliation
Klinikum Pinnerberg, Pinneberg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Höcker, M.D.
Organizational Affiliation
Dep. of Anaesthesiology, UK-SH, Campus Kiel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berthold Bein, M.D.
Organizational Affiliation
Dep. of Anaesthesiology, UK-SH, Campus Kiel
Official's Role
Study Chair
Facility Information:
Facility Name
UK-SH, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Pinnerberg, Dep. of Anaesthesiology
City
Pinneberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
25421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22037543
Citation
Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.
Results Reference
derived

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Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

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