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NCT Number: NCT01234233

Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

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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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UK-SH, Campus Kiel, Kiel, Schleswig-Holstein, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duration of preoperative active warming

Procedure

duration of prewarming by "forced air warming"

Primary outcomes

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

    Time frame: postoperative arrival at PACU (once)

    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 outcomes

  1. Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.

    Time frame: preoperatively (once) at arrival at PACU

    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.

  2. Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.

    Time frame: intraoperatively (30 min after start of surgery), once

    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.

  3. Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.

    Time frame: at postoperative arrival at PACU, once

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Acronym: THER4-1

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2010
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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