HypothermiaNCT03351036
Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?
An observational study of Hypothermia and Perioperative/Postoperative Complications, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Perioperative/Postoperative Complications, Hypothermia Following Anesthesia
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients ≥ 18 years undergoing elective surgery
Who may be able to join
- Patients ≥ 18 years undergoing elective surgery admitted to the PACU
Who cannot join
- Patients < 18 years
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
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.
Read the detailed 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.
- Keywords
- Hypothermia
- Medical subject headings
- Hypothermia, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative hypothermia
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
Measured: Immediately after arrival at PACU
Secondary outcomes (2)
Incidence of intraoperative hypothermia
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
Measured: Duration of surgical procedure
Incidence of preoperative hypothermia
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
Measured: Immediately after arrival at holding area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Change in personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Iden, University Hospital Schleswig-Holstein
- Investigators
- Jan Höcker, MD, Study director, Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351036
- Sponsor's protocol ID
- S3_Evaluation_Hypothermia
- Status last verified
- Nov 2017
- First submitted
- 7 Dec 2015
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Torossian A, Brauer A, Hocker 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.
PubMed 25837741
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?
- ClinicalTrials.gov ID
- NCT03351036
- Acronym / sponsor ID
- S3_Evaluation_Hypothermia
- Keywords
- Hypothermia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients ≥ 18 years undergoing elective surgery
Key inclusion criteria (1 listed)
- Patients ≥ 18 years undergoing elective surgery admitted to the PACU
Key exclusion criteria (2 listed)
- Patients < 18 years
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative hypothermia
Time frame: Immediately after arrival at PACU
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
2 secondary outcomes
Incidence of intraoperative hypothermia
Time frame: Duration of surgical procedure
Incidence of preoperative hypothermia
Time frame: Immediately after arrival at holding area
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Background: PubMed 25837741Torossian A, Brauer A, Hocker 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.
- S3 guideline (German)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Höcker, MD study director
Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia and Perioperative/Postoperative Complications, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative hypothermia (time frame: Immediately after arrival at PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.