Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

March 7, 2012 updated by: Dr. T. Perl, University of Göttingen

Although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome.

For not long lasting surgery without specific risk for hypothermia the standard procedure for prevention of perioperative hypothermia is insulation. However, the insulation is often not effective enough to prevent intra- and postoperative hypothermia. The implementation of a prewarming is difficult because of variable OR schedules and therefore not often applied.

In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a convective prewarming system on prevention of intra- and perioperative hypothermia (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced air warming with or without passive insulation before induction of anesthesia.

The studied prewarming device is easy to use and will be applied on the nursery ward 30-60 minutes before transfer of the patient to the OR.

Perioperative hypothermia is a common complication in general aesthesia. Perioperative hypothermia is associated with medical risks as intraoperative impaired coagulation due to reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood loss. In the postoperative course the perioperative hypothermia is especially for patients with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is uncomfortable for the patient.

The study is conducted as a multicenter, prospective, randomised controlled trial. All patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air ™). For one intervention group will additionally the insulation with the Thermoflect™ will be applied on nursery ward, the second intervention group will receive additionally a convective air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) preoperatively on study day on nursery ward.

The aim of the study is to prove the hypothesis that a preoperative insulation with a commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated with a more less incidence of periopative hypothermia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
        • UZ Gent
  • Germany
      • Göttingen, Germany, 37075
        • Department of Anesthesiology, Emergency- and Intensive Care Medicine
  • Spain
      • San Sebastian, Spain
        • Policlinica de Guipuzcoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 18 to 75 years
  • BMI from 20 to 30 kg/m2
  • Risk class ASA I to III
  • Scheduled time for surgery 30 to 120 minutes
  • Scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran
  • Ability of informed consent

Exclusion Criteria:

  • Adipositas permagna
  • Risk class ASA IV to V
  • Hypo- and Hyperthyroidism
  • Febrile infection
  • Pregnancy
  • Scheduled time for surgery < 30 or > 120 minutes
  • Known incompatibility for midazolam, remifentanil, propofol oder rocuronium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
  • No prewarming
  • Intraoperative forced air warming (Thermoflect™/Mistral Air™) (after induction of anaesthesia, before surgery starting)
  • Passive insulation with Thermoflect™ material.
  • All fluids administrated intraoperative will be warmed.
Active Comparator: Group passive prewarming
  • Passive prewarming / insulation on nursery ward before transport to the OR (Thermoflect TSCI, Amersfoort, NL)
  • Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia.
  • All fluids administrated intraoperative will be warmed.
Device: Thermoflect [TM] passive insulation
passive insulation in the preoperative phase, befor induction of anesthesia
Active Comparator: Group Active prewarming
  • Active prewarming on nursery ward before transport to the OR (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
  • Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia.
  • All fluids administrated intraoperative will be warmed.
Device: Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Core Temperature at end of surgery
Time Frame: Approximatly 120 minutes (at end of surgery)
Approximatly 120 minutes (at end of surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with intraoperative hypothermia (Core temperature < 36°C).
Time Frame: Approximatly 120 minutes (at end of surgery)
Approximatly 120 minutes (at end of surgery)
Oral temperature before induction of anaesthesia
Time Frame: at induction of anesthesia
at induction of anesthesia
Temperature at arrival in the recovery room
Time Frame: Approximatly 140 minutes after induction (at arrival in recovery room)
Approximatly 140 minutes after induction (at arrival in recovery room)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Collaborators

UZ Gent, Belgium
Policlinica de Guipuzcoa, San Sebastian, Spain

Investigators

  • Study Chair: Michel Quintel, Prof, University Göttingen, Germany
  • Principal Investigator: Thorsten Perl, MD, University Göttingen, Germany
  • Principal Investigator: Koen Reyntjens, MD, UZ Gent, Belgium
  • Principal Investigator: Juan Zamballos, Prof., Policlinica de Guipuzcoa, San Sebastian, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 23, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/4/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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