Clinical trial NCT01502163: Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
Official title: Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Hypothermia
Keywords: perioperative hypothermia
prewarming
forced air warming
insulation
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: UZ Gent, Belgium
name: Policlinica de Guipuzcoa, San Sebastian, Spain
First posted: 2011-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Core Temperature at end of surgery
timeFrame: Approximatly 120 minutes (at end of surgery)
Secondary outcomes:
measure: Number of patients with intraoperative hypothermia (Core temperature < 36°C).
timeFrame: Approximatly 120 minutes (at end of surgery)
measure: Oral temperature before induction of anaesthesia
timeFrame: at induction of anesthesia
measure: Temperature at arrival in the recovery room
timeFrame: Approximatly 140 minutes after induction (at arrival in recovery room)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Göttingen
country: Germany
facility: Department of Anesthesiology, Emergency- and Intensive Care Medicine
city: San Sebastian
country: Spain
facility: Policlinica de Guipuzcoa
Study officials:
affiliation: University Göttingen, Germany
name: Michel Quintel, Prof
role: STUDY_CHAIR
affiliation: University Göttingen, Germany
name: Thorsten Perl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent, Belgium
name: Koen Reyntjens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinica de Guipuzcoa, San Sebastian, Spain
name: Juan Zamballos, Prof.
role: PRINCIPAL_INVESTIGATOR
References: