Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering

Hypothermia Clinical Trial

— THER4-1  

Official title:

Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234233
• Other study ID #: THER-JH
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: May 12, 2016
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2016
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.

Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.

Description:

Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.

The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.

The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for minor surgery (planned duration approximately <1h).

• Age 18-75yrs,

• ASA I-II physical status

Exclusion Criteria:

• Emergency surgery,

• pregnant patients,

• patients not able to give informed consent,

• duration of surgery >2h,

• necessary postoperative mechanical ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Procedure:
• duration of preoperative active warming
duration of prewarming by "forced air warming"

Locations

Country	Name	City	State
Germany	UK-SH, Campus Kiel	Kiel	Schleswig-Holstein
Germany	Klinikum Pinnerberg, Dep. of Anaesthesiology	Pinneberg	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)	After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.	postoperative arrival at PACU (once)	No
Secondary	Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.	Sublingual and tympanic body temperature will be assessed simultaneously once at patients' preoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for assessment of data: one single measurement immediately (1 min) after patients' arrival at PACU. Afterwards: observation of patients for about 2h.	preoperatively (once) at arrival at PACU	No
Secondary	Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.	Sublingual and tympanic body temperature will be assessed simultaneously (once) 30 min after start of surgery and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 1 min after 30 min after start of surgery.Afterwards patients will be observed for about 3h.	intraoperatively (30 min after start of surgery), once	No
Secondary	Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.	Sublingual and tympanic body temperature will be assessed simultaneously (once) at patients' postoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 30 sec immediately after patients' arrival at PACU.	at postoperative arrival at PACU, once	No