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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jan Hoecker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01234233
First received: September 9, 2010
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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 Intervention
Hypothermia
Procedure: duration of preoperative active warming

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) [ Time Frame: postoperative arrival at PACU (once) ] [ Designated as safety issue: No ]
    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. [ Time Frame: preoperatively (once) at arrival at PACU ] [ Designated as safety issue: No ]
    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. [ Time Frame: intraoperatively (30 min after start of surgery), once ] [ Designated as safety issue: No ]
    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. [ Time Frame: at postoperative arrival at PACU, once ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1
Control group - no intervention: no preoperative warming
Procedure: duration of preoperative active warming
duration of prewarming by "forced air 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"

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234233

Locations
Germany
UK-SH, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Klinikum Pinnerberg, Dep. of Anaesthesiology
Pinneberg, Schleswig-Holstein, Germany, 25421
Sponsors and Collaborators
University of 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
  More Information

No publications provided by University of Schleswig-Holstein

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jan Hoecker, PD Dr. Jan Höcker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01234233     History of Changes
Other Study ID Numbers: THER-JH
Study First Received: September 9, 2010
Last Updated: October 10, 2011
Health Authority: Germany: Ministry of Health

Keywords provided by University of Schleswig-Holstein:
hypothermia, accidental
prewarming
body temperature monitoring
preoperative warming
sublingual temperature assessment
tympanic temperature assessment

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014