Preoperative WarmingTHER-6NCT01795482
Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery
A study testing Forced-air warming in people with Preoperative Warming and Prewarming, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
Trial summary
The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Warming, Prewarming, Perioperative Hypothermia
- What is being tested?
- Forced-air warming
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2013to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years
- planned duration of surgery > 2 hours
- planned for elective major abdominal surgery under combined epidural/general anaesthesia
- written informed consent
- American society of anesthesiologists status 1-3
Who cannot join
- duration of surgery < 90 min
- withdrawal of consent
- emergency surgery
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
Pinneberg, Schleswig-Holstein, 25421
About this study
Official title: The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia
The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
Read the detailed description
The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
- Conditions
- Preoperative Warming, Prewarming, Perioperative Hypothermia, General Anaesthesia, Epidural Anaesthesia, Temperature Monitoring
- Being tested
- Forced-air warming
- Keywords
- perioperative hypothermia, prewarming, preoperative warming, general anaesthesia, epidural anaesthesia, temperature measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-air warmingDevice
Also called Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower
In the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 2, Prewarming only before general anaesthesia | Experimental | Active forced-air warming for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). Receives: Device: Forced-air warming |
| Group 3, Prewarming before epidural and general anaesthesia | Experimental | Active forced-air warming for 15 min before start of epidural anaesthesia and for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). Receives: Device: Forced-air warming |
| Group 1, control group | No intervention | No active warming before start of epidural or general anaesthesia, active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypothermic patients at arrival at PACU
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature < 36°C)will be measured.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative WarmingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 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 Hoecker, M.D., Study chair, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795482
- Sponsor's protocol ID
- THER-6
- Acronym
- THER-6
- Status last verified
- Dec 2014
- First submitted
- 18 Feb 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
PubMed 22376088Hocker 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 22037543Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.
PubMed 26555870
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia
- ClinicalTrials.gov ID
- NCT01795482
- Acronym / sponsor ID
- THER-6 / THER-6
- Conditions
- Preoperative Warming, Prewarming, Perioperative Hypothermia, General Anaesthesia, Epidural Anaesthesia, Temperature Monitoring
- Keywords
- perioperative hypothermia, prewarming, preoperative warming, general anaesthesia, epidural anaesthesia, temperature measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Feb 2013 (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 study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
Detailed description
The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2, Prewarming only before general anaesthesia | Experimental | Device: Forced-air warmingActive forced-air warming for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
| Group 3, Prewarming before epidural and general anaesthesia | Experimental | Device: Forced-air warmingActive forced-air warming for 15 min before start of epidural anaesthesia and for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
| Group 1, control group | No intervention | –No active warming before start of epidural or general anaesthesia, active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 18 years
- planned duration of surgery > 2 hours
- planned for elective major abdominal surgery under combined epidural/general anaesthesia
- written informed consent
- American society of anesthesiologists status 1-3
Key exclusion criteria (3 listed)
- duration of surgery < 90 min
- withdrawal of consent
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced-air warmingAlso: Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blowerIn the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery. | Device | Group 2, Prewarming only before general anaesthesia, Group 3, Prewarming before epidural and general anaesthesia |
Primary outcome
Incidence of hypothermic patients at arrival at PACU
Time frame: 2 hours
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature < 36°C)will be measured.
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 16 Dec 2014.
- Background: PubMed 22376088Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
- Background: 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.
- Derived from this study: PubMed 26555870Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.
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Nephrectomy / Methods, Intraoperative Hypothermia
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 Hoecker, M.D. study chair
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced-air warming in people with Preoperative Warming and Prewarming, 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 5 inclusion and 3 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 16 Dec 2014. 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 patients at arrival at PACU (time frame: 2 hours). 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 NCT01795482, which also lists 3 linked publications.
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 16 Dec 2014.