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Completed

NCT Number: NCT03163563

Perioperative Hypothermia Hypothermia in Ambulatory Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aleris Solsiden

Trondheim, Sør-Trøndelag, 7014, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Easywarm

Device

Warming blanket

BairHugger

Device

Patient warming mattress with continuous warm air.

Primary outcomes

  1. Temperature

    Time frame: Perioperative period

    Temperature Celsius measured by SpotOn 3M

Secondary outcomes

  1. Medication given during study period

    Time frame: Perioperative period

    Type and dosage is registered. Ephedrine and phenylephrine are known to interact with temperature regulation.

  2. Temperature Numerical Rating Scale

    Time frame: Perioperative period.

    To identify at which temperature the patient is comfortably warm without need for warming intervention.

Sponsors and collaborators

Lead sponsor

Aleris Helse

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 23, 2017
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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