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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03351036
Other study ID # S3_Evaluation_Hypothermia
Secondary ID
Status Withdrawn
Phase N/A
First received December 7, 2015
Last updated November 18, 2017
Start date April 2015
Est. completion date May 2016

Study information

Verified date November 2017
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning it´s implementation in the clinical routine.


Description:

Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events such as impaired coagulation, increased risk for wound infections and patient discomfort among others. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia published in 2014 concerning it´s implementation in the clinical routine. In a first phase the current status should be recorded. If this reveals an inappropriate high incidence of perioperative hypothermia training arrangements shall be taken for non-physician personnel in the PACU in a 2nd phase of the project. The third phase is intended to evaluate the effect of the training arrangements on the incidence of hypothermia.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients = 18 years undergoing elective surgery admitted to the PACU

Exclusion Criteria:

- Patients < 18 years

- Emergency surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Schleswig-Holstein, Campus Kiel Kiel Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Torossian A, Bräuer A, Höcker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative hypothermia Evaluation of the S3 guideline on avoidance of perioperative hypothermia Immediately after arrival at PACU
Secondary Incidence of intraoperative hypothermia Evaluation of the S3 guideline on avoidance of perioperative hypothermia Duration of surgical procedure
Secondary Incidence of preoperative hypothermia Evaluation of the S3 guideline on avoidance of perioperative hypothermia Immediately after arrival at holding area
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