NCT01234233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

September 9, 2010

Last Update Submit

May 12, 2016

Conditions

Hypothermia

Keywords

hypothermia, accidentalprewarmingbody temperature monitoringpreoperative warmingsublingual temperature assessmenttympanic temperature assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    postoperative arrival at PACU (once)

Secondary Outcomes (3)

  • 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

Study Arms (4)

Group 1

NO INTERVENTION

Control group - no intervention: no preoperative warming

Group 2 - 10 min prewarming

ACTIVE COMPARATOR

10 min prewarming preoperatively

Procedure: duration of preoperative active warming

Group 3 - 20 min prewarming

ACTIVE COMPARATOR

20 min prewarming preoperatively

Procedure: duration of preoperative active warming

Group 4 - 30 min prewarming

ACTIVE COMPARATOR

30 min prewarming preoperatively

Procedure: duration of preoperative active warming

Interventions

duration of preoperative active warmingPROCEDURE

duration of prewarming by "forced air warming"

Group 2 - 10 min prewarmingGroup 3 - 20 min prewarmingGroup 4 - 30 min prewarming

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for minor surgery (planned duration approximately \<1h).
  • Age 18-75yrs,
  • ASA I-II physical status

You may not qualify if:

  • Emergency surgery,
  • pregnant patients,
  • patients not able to give informed consent,
  • duration of surgery \>2h,
  • necessary postoperative mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UK-SH, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Klinikum Pinnerberg, Dep. of Anaesthesiology

Pinneberg, Schleswig-Holstein, 25421, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22037543DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Steinfath, M.D.

    Dep. of Anaesthesiology, UK-SH, Campus Kiel

    STUDY DIRECTOR

  • Ernst P Horn, M.D.

    Klinikum Pinnerberg, Pinneberg, Germany

    PRINCIPAL INVESTIGATOR

  • Jan Höcker, M.D.

    Dep. of Anaesthesiology, UK-SH, Campus Kiel

    PRINCIPAL INVESTIGATOR

  • Berthold Bein, M.D.

    Dep. of Anaesthesiology, UK-SH, Campus Kiel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Jan Höcker

Study Record Dates

First Submitted

September 9, 2010

First Posted

November 4, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

DE(2)