HypothermiaNCT02206997
Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia
An observational study of Hypothermia and Hypothermia, Accidental, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Hypothermia, Accidental
- How many people
- 485 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions (see below)
Who may be able to join
- patients scheduled for elective general or orthopedic surgery with expected duration > 45 min
- American Society of Anesthesiologists physical status 1-3
- age > 17 years
Who cannot join
- emergency surgery
- patient's denial
- unexpected decrease of duration of anesthesia < 45 min
- preoperative body temperature > 38 °C
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the detailed description
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).
- Conditions
- Hypothermia, Hypothermia, Accidental
- Keywords
- perioperative hypothermia, prewarming, treatment guideline
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative hypothermia at admission to PACU
The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.
Measured: admission to PACU
Secondary outcomes (1)
Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU
Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?
Measured: admission to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Jan Hoecker, University Hospital Schleswig-Holstein
- Investigators
- Jan H Hoecker, MD, Principal investigator, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206997
- Sponsor's protocol ID
- THER-GUIDE-EVA
- Status last verified
- May 2017
- First submitted
- 30 Jul 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02206997
- Acronym / sponsor ID
- THER-GUIDE-EVA
- Conditions
- Hypothermia, Hypothermia, Accidental
- Keywords
- perioperative hypothermia, prewarming, treatment guideline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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.
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).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions (see below)
Key inclusion criteria (3 listed)
- patients scheduled for elective general or orthopedic surgery with expected duration > 45 min
- American Society of Anesthesiologists physical status 1-3
- age > 17 years
Key exclusion criteria (4 listed)
- emergency surgery
- patient's denial
- unexpected decrease of duration of anesthesia < 45 min
- preoperative body temperature > 38 °C
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 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.
1 secondary outcome
Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU
Time frame: admission to PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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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 H Hoecker, MD principal investigator
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
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 Hypothermia, Accidental, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 at admission to PACU (time frame: admission to PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017.