HypothermiaTHER4-1NCT01234233
Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering
A study testing duration of preoperative active warming in people with Hypothermia, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
Trial summary
The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients. Patients will be randomly assigned to 4 groups with different duration of prewarming. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- duration of preoperative active warming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2010to May 2011
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for minor surgery (planned duration approximately <1h).
- Age 18-75yrs,
- ASA I-II physical status
Who cannot join
- Emergency surgery,
- pregnant patients,
- patients not able to give informed consent,
- duration of surgery >2h,
- necessary postoperative mechanical ventilation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
UK-SH, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Klinikum Pinnerberg, Dep. of Anaesthesiology
Pinneberg, Schleswig-Holstein, 25421
About this study
Official title: Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.
The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.
Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
Read the detailed description
Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.
The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.
The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
- Conditions
- Hypothermia
- Being tested
- duration of preoperative active warming
- Keywords
- hypothermia, accidental, prewarming, body temperature monitoring, preoperative warming, sublingual temperature assessment, tympanic temperature assessment
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration of preoperative active warmingProcedure or surgery
duration of prewarming by "forced air warming"
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Control group - no intervention: no preoperative warming |
| Group 2 - 10 min prewarming | Active comparator | 10 min prewarming preoperatively Receives: Procedure: duration of preoperative active warming |
| Group 3 - 20 min prewarming | Active comparator | 20 min prewarming preoperatively Receives: Procedure: duration of preoperative active warming |
| Group 4 - 30 min prewarming | Active comparator | 30 min prewarming preoperatively Receives: Procedure: duration of preoperative active warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.
Measured: postoperative arrival at PACU (once)
Secondary outcomes (3)
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.
Sublingual and tympanic body temperature will be assessed simultaneously once at patients' preoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for assessment of data: one single measurement immediately (1 min) after patients' arrival at PACU. Afterwards: observation of patients for about 2h.
Measured: preoperatively (once) at arrival at PACU
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.
Sublingual and tympanic body temperature will be assessed simultaneously (once) 30 min after start of surgery and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 1 min after 30 min after start of surgery.Afterwards patients will be observed for about 3h.
Measured: intraoperatively (30 min after start of surgery), once
Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.
Sublingual and tympanic body temperature will be assessed simultaneously (once) at patients' postoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 30 sec immediately after patients' arrival at PACU.
Measured: at postoperative arrival at PACU, once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMay 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 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
- Markus Steinfath, M.D., Study director, Dep. of Anaesthesiology, UK-SH, Campus KielErnst P Horn, M.D., Principal investigator, Klinikum Pinnerberg, Pinneberg, GermanyJan Höcker, M.D., Principal investigator, Dep. of Anaesthesiology, UK-SH, Campus KielBerthold Bein, M.D., Study chair, Dep. of Anaesthesiology, UK-SH, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234233
- Sponsor's protocol ID
- THER-JH
- Acronym
- THER4-1
- Status last verified
- May 2016
- First submitted
- 9 Sep 2010
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.
PubMed 22037543
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.
- ClinicalTrials.gov ID
- NCT01234233
- Acronym / sponsor ID
- THER4-1 / THER-JH
- Conditions
- Hypothermia
- Keywords
- hypothermia, accidental, prewarming, body temperature monitoring, preoperative warming, sublingual temperature assessment, tympanic temperature assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Nov 2010 (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 investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.
Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
Detailed description
Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.
The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.
The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Control group - no intervention: no preoperative warming |
| Group 2 - 10 min prewarming | Active comparator | Procedure: duration of preoperative active warming10 min prewarming preoperatively |
| Group 3 - 20 min prewarming | Active comparator | Procedure: duration of preoperative active warming20 min prewarming preoperatively |
| Group 4 - 30 min prewarming | Active comparator | Procedure: duration of preoperative active warming30 min prewarming preoperatively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for minor surgery (planned duration approximately <1h).
- Age 18-75yrs,
- ASA I-II physical status
Key exclusion criteria (5 listed)
- Emergency surgery,
- pregnant patients,
- patients not able to give informed consent,
- duration of surgery >2h,
- necessary postoperative mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duration of preoperative active warmingduration of prewarming by "forced air warming" | Procedure or surgery | Group 2 - 10 min prewarming, Group 3 - 20 min prewarming, Group 4 - 30 min prewarming |
Primary outcome
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
Time frame: postoperative arrival at PACU (once)
After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.
3 secondary outcomes
Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.
Time frame: preoperatively (once) at arrival at PACU
Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.
Time frame: intraoperatively (30 min after start of surgery), once
Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.
Time frame: at postoperative arrival at PACU, once
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 13 May 2016.
- Derived from this study: PubMed 22037543Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.
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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.
Markus Steinfath, M.D. study director
Dep. of Anaesthesiology, UK-SH, Campus Kiel
Ernst P Horn, M.D. principal investigator
Klinikum Pinnerberg, Pinneberg, Germany
Jan Höcker, M.D. principal investigator
Dep. of Anaesthesiology, UK-SH, Campus Kiel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duration of preoperative active warming in people with Hypothermia, run by University Hospital Schleswig-Holstein at 2 sites 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 5 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) (time frame: postoperative arrival at PACU (once)). 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 NCT01234233, 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 13 May 2016.