Perioperative HypothermiaNCT01502163
Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
A study testing Thermoflect [TM] passive insulation and Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) in people with Perioperative Hypothermia, run by University of Göttingen at 3 sites in 3 countries.
Trial summary
Although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perioperative Hypothermia
- What is being tested?
- Thermoflect [TM] passive insulation and Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2011to Feb 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years
- BMI from 20 to 30 kg/m2
- Risk class ASA I to III
- Scheduled time for surgery 30 to 120 minutes
- Scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran
- Ability of informed consent
Who cannot join
- Adipositas permagna
- Risk class ASA IV to V
- Hypo- and Hyperthyroidism
- Febrile infection
- Pregnancy
- Scheduled time for surgery < 30 or > 120 minutes
- Known incompatibility for midazolam, remifentanil, propofol oder rocuronium
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Department of Anesthesiology, Emergency- and Intensive Care Medicine
Göttingen, 37075
About this study
Although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome.
For not long lasting surgery without specific risk for hypothermia the standard procedure for prevention of perioperative hypothermia is insulation. However, the insulation is often not effective enough to prevent intra- and postoperative hypothermia. The implementation of a prewarming is difficult because of variable OR schedules and therefore not often applied.
Read more
In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a convective prewarming system on prevention of intra- and perioperative hypothermia (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced air warming with or without passive insulation before induction of anesthesia.
The studied prewarming device is easy to use and will be applied on the nursery ward 30-60 minutes before transfer of the patient to the OR.
Perioperative hypothermia is a common complication in general aesthesia. Perioperative hypothermia is associated with medical risks as intraoperative impaired coagulation due to reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood loss. In the postoperative course the perioperative hypothermia is especially for patients with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is uncomfortable for the patient.
The study is conducted as a multicenter, prospective, randomised controlled trial. All patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air ™). For one intervention group will additionally the insulation with the Thermoflect™ will be applied on nursery ward, the second intervention group will receive additionally a convective air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) preoperatively on study day on nursery ward.
The aim of the study is to prove the hypothesis that a preoperative insulation with a commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated with a more less incidence of periopative hypothermia.
- Conditions
- Perioperative Hypothermia
- Being tested
- Thermoflect [TM] passive insulation, Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
- Keywords
- perioperative hypothermia, prewarming, forced air warming, insulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoflect [TM] passive insulationDevice
passive insulation in the preoperative phase, befor induction of anesthesia
Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)Device
Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | * No prewarming * Intraoperative forced air warming (Thermoflect™/Mistral Air™) (after induction of anaesthesia, before surgery starting) * Passive insulation with Thermoflect™ material. * All fluids administrated intraoperative will be warmed. |
| Group passive prewarming | Active comparator | * Passive prewarming / insulation on nursery ward before transport to the OR (Thermoflect TSCI, Amersfoort, NL)
* Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia.
* All fluids administrated intraoperative will be warmed. Receives: Device: Thermoflect [TM] passive insulation |
| Group Active prewarming | Active comparator | * Active prewarming on nursery ward before transport to the OR (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)
* Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia.
* All fluids administrated intraoperative will be warmed. Receives: Device: Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature at end of surgery
Measured: Approximatly 120 minutes (at end of surgery)
Secondary outcomes (3)
Number of patients with intraoperative hypothermia (Core temperature < 36°C).
Measured: Approximatly 120 minutes (at end of surgery)
Oral temperature before induction of anaesthesia
Measured: at induction of anesthesia
Temperature at arrival in the recovery room
Measured: Approximatly 140 minutes after induction (at arrival in recovery room)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Policlinica de Guipuzcoa, San Sebastian, Spain
- Responsible party
- Principal investigator, Dr. T. Perl, University of Göttingen
- Investigators
- Michel Quintel, Prof, Study chair, University Göttingen, GermanyThorsten Perl, MD, Principal investigator, University Göttingen, GermanyKoen Reyntjens, MD, Principal investigator, University Hospital, GhentJuan Zamballos, Prof., Principal investigator, Policlinica de Guipuzcoa, San Sebastian, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502163
- Sponsor's protocol ID
- 11/4/11
- Status last verified
- Mar 2012
- First submitted
- 23 Dec 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia
- ClinicalTrials.gov ID
- NCT01502163
- Acronym / sponsor ID
- 11/4/11
- Conditions
- Perioperative Hypothermia
- Keywords
- perioperative hypothermia, prewarming, forced air warming, insulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Policlinica de Guipuzcoa, San Sebastian, Spain
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Dec 2011 (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.
Although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome.
For not long lasting surgery without specific risk for hypothermia the standard procedure for prevention of perioperative hypothermia is insulation. However, the insulation is often not effective enough to prevent intra- and postoperative hypothermia. The implementation of a prewarming is difficult because of variable OR schedules and therefore not often applied.
In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a convective prewarming system on prevention of intra- and perioperative hypothermia (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced air warming with or without passive insulation before induction of anesthesia.
The studied prewarming device is easy to use and will be applied on the nursery ward 30-60 minutes before transfer of the patient to the OR.
Perioperative hypothermia is a common complication in general aesthesia. Perioperative hypothermia is associated with medical risks as intraoperative impaired coagulation due to reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood loss. In the postoperative course the perioperative hypothermia is especially for patients with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is uncomfortable for the patient.
The study is conducted as a multicenter, prospective, randomised controlled trial. All patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air ™). For one intervention group will additionally the insulation with the Thermoflect™ will be applied on nursery ward, the second intervention group will receive additionally a convective air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) preoperatively on study day on nursery ward.
The aim of the study is to prove the hypothesis that a preoperative insulation with a commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated with a more less incidence of periopative hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –* No prewarming * Intraoperative forced air warming (Thermoflect™/Mistral Air™) (after induction of anaesthesia, before surgery starting) * Passive insulation with Thermoflect™ material. * All fluids administrated intraoperative will be warmed. |
| Group passive prewarming | Active comparator | Device: Thermoflect [TM] passive insulation* Passive prewarming / insulation on nursery ward before transport to the OR (Thermoflect TSCI, Amersfoort, NL) * Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia. * All fluids administrated intraoperative will be warmed. |
| Group Active prewarming | Active comparator | Device: Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)* Active prewarming on nursery ward before transport to the OR (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) * Intraoperative forced air warming (Thermoflect™ / Mistral Air ™) The forced air warming will be applied after induction of anaesthesia. * All fluids administrated intraoperative will be warmed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 75 years
- BMI from 20 to 30 kg/m2
- Risk class ASA I to III
- Scheduled time for surgery 30 to 120 minutes
- Scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran
Key exclusion criteria (7 listed)
- Adipositas permagna
- Risk class ASA IV to V
- Hypo- and Hyperthyroidism
- Febrile infection
- Pregnancy
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 |
|---|---|---|
| Thermoflect [TM] passive insulationpassive insulation in the preoperative phase, befor induction of anesthesia | Device | Group passive prewarming |
| Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia | Device | Group Active prewarming |
Primary outcome
Core Temperature at end of surgery
Time frame: Approximatly 120 minutes (at end of surgery)
3 secondary outcomes
Number of patients with intraoperative hypothermia (Core temperature < 36°C).
Time frame: Approximatly 120 minutes (at end of surgery)
Oral temperature before induction of anaesthesia
Time frame: at induction of anesthesia
Temperature at arrival in the recovery room
Time frame: Approximatly 140 minutes after induction (at arrival in recovery room)
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 8 Mar 2012.
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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.
Michel Quintel, Prof study chair
University Göttingen, Germany
Thorsten Perl, MD principal investigator
University Göttingen, Germany
Koen Reyntjens, MD principal investigator
University Hospital, Ghent
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoflect [TM] passive insulation and Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) in people with Perioperative Hypothermia, run by University of Göttingen at 3 sites in 3 countries.
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 6 inclusion and 7 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Spain. 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?
Core Temperature at end of surgery (time frame: Approximatly 120 minutes (at end of surgery)). 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 8 Mar 2012.