Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

Perioperative Hypothermia Clinical Trial

Official title:

Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502163
• Other study ID #: 11/4/11
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: March 7, 2012
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Perioperative Hypothermia

Intervention

Device:
• Thermoflect [TM] passive insulation
passive insulation in the preoperative phase, befor induction of anesthesia
• Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Germany	Department of Anesthesiology, Emergency- and Intensive Care Medicine	Göttingen
Spain	Policlinica de Guipuzcoa	San Sebastian

Sponsors (3)

Lead Sponsor	Collaborator
University of Göttingen	Policlinica de Guipuzcoa, San Sebastian, Spain, UZ Gent, Belgium

Countries where clinical trial is conducted

Belgium,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Temperature at end of surgery		Approximatly 120 minutes (at end of surgery)	No
Secondary	Number of patients with intraoperative hypothermia (Core temperature < 36°C).		Approximatly 120 minutes (at end of surgery)	No
Secondary	Oral temperature before induction of anaesthesia		at induction of anesthesia	No
Secondary	Temperature at arrival in the recovery room		Approximatly 140 minutes after induction (at arrival in recovery room)	No