Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

NCT01502163 | Completed

• 1 other identifier: 11/4/11
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 3

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.

Conditions

Perioperative Hypothermia

Keywords

perioperative hypothermia; prewarming; forced air warming; insulation

Outcome Measures

Primary Outcomes (1)

• Core Temperature at end of surgery

  Approximatly 120 minutes (at end of surgery)

Secondary Outcomes (3)

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

  Approximatly 120 minutes (at end of surgery)

• Oral temperature before induction of anaesthesia

  at induction of anesthesia

• Temperature at arrival in the recovery room

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

Study Arms (3)

Control

NO INTERVENTION

* 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.

Group passive prewarming

ACTIVE COMPARATOR

* 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

Group Active prewarming

ACTIVE COMPARATOR

* 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)

Interventions

Thermoflect [TM] passive insulation DEVICE

passive insulation in the preoperative phase, befor induction of anesthesia

Group passive prewarming

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

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

Group Active prewarming

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead
• UZ Gent, Belgium: collaborator
• Policlinica de Guipuzcoa, San Sebastian, Spain: collaborator

Study Sites (3)

UZ Gent

Ghent, Belgium

Location

Department of Anesthesiology, Emergency- and Intensive Care Medicine

Göttingen, 37075, Germany

Location

Policlinica de Guipuzcoa

Donostia / San Sebastian, Spain

Location

Study Officials

• Michel Quintel, Prof

  University Göttingen, Germany

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 30, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

ES (1); BE (1); DE (1)