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NCT Number: NCT02206997

Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia

The aim of the study is to evaluate a patient prewarming concept following the recommendations of the S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following actual standard protocol (passive insulation).

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Key information

Conditions

Hypothermia Body Temperature Changes Hypothermia, Accidental Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FEK Hospital Neumünster

Neumünster, Schleswig-Holstein, 24534, Germany

About this study

The aim of the study is to evaluate a patient prewarming concept following the recommendations of the new german S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. Prewarming should enable the patients to preserve their core temperature for a longer period and to avoid perioperative hypothermia.The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following the actual standard protocol (passive insulation).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients scheduled for elective general or orthopedic surgery with expected duration > 45 min
  • American Society of Anesthesiologists physical status 1-3
  • age > 17 years

Exclusion criteria

  • emergency surgery
  • patient's denial
  • unexpected decrease of duration of anesthesia < 45 min
  • preoperative body temperature > 38 °C

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative hypothermia at admission to PACU

    Time frame: admission to PACU

    The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.

Secondary outcomes

  1. Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU

    Time frame: admission to PACU

    Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Evaluation of a Patient Warming Concept Following the New German Speaking S3 Guideline for Prevention of Intraoperative Hypothermia With Respect to Incidence and Complications of Perioperative Hypothermia

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2014
Registry last updated
May 4, 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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