NormothermiaNCT00913978
Perioperative Active Warming Techniques in Colorectal Surgeries
A study testing Group 1: VitaHeat and Group 2: Bair Hugger in people with Normothermia, run by Northwestern University at 2 sites in United States.
Trial summary
We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normothermia
- What is being tested?
- Group 1: VitaHeat and Group 2: Bair Hugger
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2017to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.
Who cannot join
- Any patient who is less than 18 years old.
- Emergent surgery
- Any patient with thyroid problems
- Any patient with preoperative fever
- Any patient who is pregnant
- Any adult patients unable to consent
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
About this study
Official title: A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries
We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.
Read the detailed description
Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery.
Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.
Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.
Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.
Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area.
Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.
- Conditions
- Normothermia
- Being tested
- Group 1: VitaHeat, Group 2: Bair Hugger
- Keywords
- Normothermia, Colorectal Surgery, Bair Huggers, VitaHeat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: VitaHeatDevice
Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Group 2: Bair HuggerDevice
Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VitaHeat | Active comparator | Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Receives: Device: Group 1: VitaHeat |
| Group 2: Bair Hugger | Active comparator | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Receives: Device: Group 2: Bair Hugger |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.
The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.
Measured: 1 day
Secondary outcomes (1)
Post Operative Temperature on Admission to Post Operative Care Unit (PACU)
Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study start13 Apr 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Why it stopped: Study terminated due to financial status of sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for NormothermiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Yilmaz, Northwestern University
- Investigators
- Meltim Yilmaz, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913978
- Sponsor's protocol ID
- STU00202644
- Status last verified
- Jan 2020
- First submitted
- 2 Jun 2009
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
PubMed 19137809Sessler DI, Schroeder M. Heat loss in humans covered with cotton hospital blankets. Anesth Analg. 1993 Jul;77(1):73-7. doi: 10.1213/00000539-199307000-00014.
PubMed 8317751Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology. 1994 Apr;80(4):806-10. doi: 10.1097/00000542-199404000-00012.
PubMed 8024134Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
PubMed 15114200Janicki PK, Higgins MS, Janssen J, Johnson RF, Beattie C. Comparison of two different temperature maintenance strategies during open abdominal surgery: upper body forced-air warming versus whole body water garment. Anesthesiology. 2001 Oct;95(4):868-74. doi: 10.1097/00000542-200110000-00014.
PubMed 11605926Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
PubMed 1610573Brauer A, Weyland W, Kazmaier S, Trostdorf U, Textor Z, Hellige G, Braun U. Efficacy of postoperative rewarming after cardiac surgery. Ann Thorac Cardiovasc Surg. 2004 Jun;10(3):171-7.
PubMed 15312013Smith CE, Desai R, Glorioso V, Cooper A, Pinchak AC, Hagen KF. Preventing hypothermia: convective and intravenous fluid warming versus convective warming alone. J Clin Anesth. 1998 Aug;10(5):380-5. doi: 10.1016/s0952-8180(98)00049-x.
PubMed 9702617Negishi C, Hasegawa K, Mukai S, Nakagawa F, Ozaki M, Sessler DI. Resistive-heating and forced-air warming are comparably effective. Anesth Analg. 2003 Jun;96(6):1683-1687. doi: 10.1213/01.ANE.0000062770.73862.B7.
PubMed 12760996Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f.
PubMed 23989047
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries
- ClinicalTrials.gov ID
- NCT00913978
- Acronym / sponsor ID
- STU00202644
- Conditions
- Normothermia
- Keywords
- Normothermia, Colorectal Surgery, Bair Huggers, VitaHeat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to financial status of sponsor.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.
Detailed description
Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery.
Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.
Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.
Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.
Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area.
Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: VitaHeat | Active comparator | Device: Group 1: VitaHeatPatients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. |
| Group 2: Bair Hugger | Active comparator | Device: Group 2: Bair HuggerPatients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.
Key exclusion criteria (7 listed)
- Any patient who is less than 18 years old.
- Emergent surgery
- Any patient with thyroid problems
- Any patient with preoperative fever
- Any patient who is pregnant
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 |
|---|---|---|
| Group 1: VitaHeatPatients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. | Device | Group 1: VitaHeat |
| Group 2: Bair HuggerPatients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. | Device | Group 2: Bair Hugger |
Primary outcome
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.
Time frame: 1 day
The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.
1 secondary outcome
Post Operative Temperature on Admission to Post Operative Care Unit (PACU)
Time frame: Immediately after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- Background: PubMed 19137809Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
- Background: PubMed 8317751Sessler DI, Schroeder M. Heat loss in humans covered with cotton hospital blankets. Anesth Analg. 1993 Jul;77(1):73-7. doi: 10.1213/00000539-199307000-00014.
- Background: PubMed 8024134Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology. 1994 Apr;80(4):806-10. doi: 10.1097/00000542-199404000-00012.
- Background: PubMed 15114200Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
- Background: PubMed 11605926Janicki PK, Higgins MS, Janssen J, Johnson RF, Beattie C. Comparison of two different temperature maintenance strategies during open abdominal surgery: upper body forced-air warming versus whole body water garment. Anesthesiology. 2001 Oct;95(4):868-74. doi: 10.1097/00000542-200110000-00014.
- Background: PubMed 1610573Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
- Background: PubMed 15312013Brauer A, Weyland W, Kazmaier S, Trostdorf U, Textor Z, Hellige G, Braun U. Efficacy of postoperative rewarming after cardiac surgery. Ann Thorac Cardiovasc Surg. 2004 Jun;10(3):171-7.
- Background: PubMed 9702617Smith CE, Desai R, Glorioso V, Cooper A, Pinchak AC, Hagen KF. Preventing hypothermia: convective and intravenous fluid warming versus convective warming alone. J Clin Anesth. 1998 Aug;10(5):380-5. doi: 10.1016/s0952-8180(98)00049-x.
- Background: PubMed 12760996Negishi C, Hasegawa K, Mukai S, Nakagawa F, Ozaki M, Sessler DI. Resistive-heating and forced-air warming are comparably effective. Anesth Analg. 2003 Jun;96(6):1683-1687. doi: 10.1213/01.ANE.0000062770.73862.B7.
- Background: PubMed 23989047Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f.
- Individual participant dataSharing planned: No
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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.
Meltim Yilmaz, M.D. principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: VitaHeat and Group 2: Bair Hugger in people with Normothermia, run by Northwestern University at 2 sites in United States.
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 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: stopped early, as of the sponsor's last update on 13 Jan 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. (time frame: 1 day). 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 NCT00913978, which also lists 11 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 13 Jan 2020.