Perioperative Hypothermia Hypothermia in Ambulatory Surgery

Perioperative/Postoperative Complications Clinical Trial

Official title:

Perioperative Hypothermia Hypothermia in Ambulatory Surgery by Self-warming or Forced-air Warming Blanket, a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163563
• Other study ID #: 2015/1481
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: May 21, 2017
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Aleris Helse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.

Description:

Background:

Anesthesia medicaments given in general anesthesia cause impaired thermoregulation and thermogenesis. After induction of general anesthesia the core temperature is reduced to redistribution of blood from the body core to the cooler skin. Later impaired thermogenesis contributes to further loss of heat.

Mild hypothermia (<36 degrees Celsius) contributes to increased incidence of wound infections, prolonged stay in the post anesthesia care unit, shivering and reduced patient comfort.

There are several effective interventions to prevent hypothermia such as active warming pre-, per- and postoperatively. Preheated intravenous fluids and medical interventions to alter the blood distribution from the periphery to the body core have been effective in preventing hypothermia.

In the department both self-warming blanket (Easywarm®) and forced-air blanket (BairHugger®) are routinely used to prevent hypothermia. It has been observed that a few patients undergoing plastic surgery with anesthesia time more than one hour are shivering and feeling cold in the postoperative period.

Purpose:

The purpose of the study is to observe and measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.

Design:

The is a quality assurance study deigned as a prospective randomised trial. With a validated non-invasive termometer (SpotOn® 3M) temperature is measured before, during and after surgical procedures in general anesthesia. An equal number of notes with the number 1 and 2 were put into an envelope (1=EasyWarm®, 2=BairHugger®). For each operation theater a note is drawn, and all patients in that operation theater receives active warming according to the number on the note.

Population data:

Sex, age , weight, height, BMI, medication, morbidities and ASA class will be registered.

Measurements:

• temperature (Celsius)

• Blood pressure

• Heartrate

• SaO2

• Temperature-comfort "numeric rating scale" (NRS)

Other registrations:

• Medicines given during the study period.

• Start and end of anesthesia and surgery

• Time when temperature is above or eual to 36 degrees Celsius.

• Time when the patient go home

Data is collected and registered on a dataform. Data are analysed in a anonymized excel workbook.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients for planned plastic surgery with duration of general anesthesia = 60 minutes.

Exclusion Criteria:

Related Conditions & MeSH terms

• Hypothermia
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Device:
• Easywarm
Warming blanket
• BairHugger
Patient warming mattress with continuous warm air.

Locations

Country	Name	City	State
Norway	Aleris Solsiden	Trondheim	Sør-Trøndelag

Sponsors (1)

Lead Sponsor	Collaborator
Aleris Helse

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature	Temperature Celsius measured by SpotOn 3M	Perioperative period
Secondary	Medication given during study period	Type and dosage is registered. Ephedrine and phenylephrine are known to interact with temperature regulation.	Perioperative period
Secondary	Temperature Numerical Rating Scale	To identify at which temperature the patient is comfortably warm without need for warming intervention.	Perioperative period.