NCT02206997

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
485

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

July 30, 2014

Last Update Submit

May 1, 2017

Conditions

HypothermiaHypothermia, Accidental

Keywords

perioperative hypothermiaprewarmingtreatment guideline

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative hypothermia at admission to PACU

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

    admission to PACU

Secondary Outcomes (1)

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

    admission to PACU

Study Arms (2)

Passive Insulation standard treatment

no active warming before start of anesthesia and no active warming at PACU

Active prewarming treatment

active warming before start of anesthesia and active warming at PACU following recommendations of S3-guideline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions (see below)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FEK Hospital Neumünster

Neumünster, Schleswig-Holstein, 24534, Germany

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan H Hoecker, MD

    University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

DE(1)