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NCT Number: NCT01502163

Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Thermoflect [TM] passive insulation

Device

passive insulation in the preoperative phase, befor induction of anesthesia

Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)

Device

Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia

Primary outcomes

  1. Core Temperature at end of surgery

    Time frame: Approximatly 120 minutes (at end of surgery)

Secondary outcomes

  1. Number of patients with intraoperative hypothermia (Core temperature < 36°C).

    Time frame: Approximatly 120 minutes (at end of surgery)

  2. Oral temperature before induction of anaesthesia

    Time frame: at induction of anesthesia

  3. Temperature at arrival in the recovery room

    Time frame: Approximatly 140 minutes after induction (at arrival in recovery room)

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 30, 2011
Registry last updated
Mar 8, 2012

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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