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Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01502163
Enrollment
90
Registered
2011-12-30
Start date
2011-10-31
Completion date
2012-02-29
Last updated
2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Hypothermia

Keywords

perioperative hypothermia, prewarming, forced air warming, insulation

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.

Interventions

DEVICEThermoflect [TM] passive insulation

passive insulation in the preoperative phase, befor induction of anesthesia

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

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

Sponsors

UZ Gent, Belgium
CollaboratorUNKNOWN
Policlinica de Guipuzcoa, San Sebastian, Spain
CollaboratorUNKNOWN
University of Göttingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Core Temperature at end of surgeryApproximatly 120 minutes (at end of surgery)

Secondary

MeasureTime frame
Number of patients with intraoperative hypothermia (Core temperature < 36°C).Approximatly 120 minutes (at end of surgery)
Oral temperature before induction of anaesthesiaat induction of anesthesia
Temperature at arrival in the recovery roomApproximatly 140 minutes after induction (at arrival in recovery room)

Countries

Belgium, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026