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Poor participant recruitment
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This prospective randomized clinical trial will assess the effect of pre-operative convective warming on intra-operative thermoregulation in patients undergoing gastrointestinal or genitourinary surgical procedures with the Tiger anesthesia perioperative protocol.
By the year 2030 the geriatric presence in the United States, defined as any adult >65 years of age, is estimated to reach around 20% of the entire population. Thus, understanding medical concepts as they relate to the elderly is becoming increasingly important. One such concept is that of hypothermia - a core body temperature < 36°C - for which age >65 has been found to be an independent risk factor. This complication is especially prevalent intra-operatively due to use of general anesthetics, cool ambient operating room (OR) temperatures, and impaired thermal regulation in the elderly.
The human body employs numerous mechanisms to maintain thermal homeostasis including: behavioral means of thermoregulation, sweating, pre-capillary vasodilation, non-shivering and shivering means of heat production, and arteriovenous shunt vasoconstriction. The first, and arguably most important, regulatory response to occur is that of vasoconstriction, which normally results in redistribution of blood from the relatively cool periphery to the warmer core compartment in order to confine metabolic heat to the central tissues. Patients undergoing general anesthesia experience reduced vasoconstriction due to decreased cold response thresholds while patients undergoing epidural anesthesia experience sympathetic blocks resulting in blunted vasoconstrictive responses. All patients experience the afore mentioned side effects of anesthetics, however it has been proven that the elderly are more susceptible to hypothermia due to lower vasoconstriction thresholds - determined by a temperature gradient of 4°C between the periphery and core.
First explored by Kurz et al. in 1993, it was found that use of nitrous oxide and isoflurane anesthesia lead to an approximately 1.2°C lower vasoconstriction threshold of 33.9±0.6 in the elderly versus 35.1±0.3 in the young (p < .01). This subject was again looked at in a 1997 study wherein the vasoconstriction threshold during nitrous oxide and sevoflurane was observed to be decreased by approximately 0.8°C in the elderly at 35.0±0.8 versus 35.8±0.3 in the young (p < .01). This is relevant because intraoperative hypothermia has long been known to lead to adverse outcomes such as increased incidence of myocardial ischemia, arrhythmias, coagulopathic states, and wound infections. In a 2014 retrospective cohort study by Billeter et al. patient's experiencing core temperatures <35°C had a four times increase in mortality with complication rates increasing two fold and incidence of stroke increasing six fold. To counter this thermoregulatory failure in patients, numerous methods of warming have been practiced over time to augment the normal body response.
One method used to decrease intraoperative hypothermia is warming patients before surgery via skin surface warmers. Numerous studies have found that even brief periods of pre-warming can improve intraoperative temperatures significantly for as long as 75-90 minutes after induction. In procedures lasting less than 90 minutes, Horn et al. found that as little as 10 minutes of pre-warming decreased incidence of intraoperative hypothermia from 69% to just 13% while Torossian et al. decreased the incidence from 60% to 38% in his study using a self-warming blanket for 30 minutes pre-operatively. Studies have also shown that longer pre-warming, of 45-60 minutes, can prevent hypothermia for up to 2 hours after induction.
While significant research has been performed on the effects of warming patients before they undergo surgical procedures, scant evidence demonstrates the effect of pre-warming in the elderly. In one article specifically looking at pre-warming in the elderly (mean age ~72-73) it was found that, after pre-warming for 20 minutes, there was no significant change in incidence of hypothermia but there was a significant difference in severity of hypothermia when it did occur. This study focused only on men undergoing transurethral resection of the prostate however, and suffers from lack of generalizability. With the proportion of the geriatric population continuing to expand, and the potential adverse effects resulting from their increased susceptibility to intraoperative hypothermia, it is of the utmost importance to look into methods to counter this dilemma and expand the database on the topic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convective pre-warming | Experimental | Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room |
|
| Standard of care | No Intervention | Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bair Hugger™ Temperature Management Unit Model 750 | Device | Forced-air temperature management unit used for preoperative and intraoperative participant warming |
|
| Measure | Description | Time Frame |
|---|---|---|
| Core Body Temperature | Change in core temperature between induction of anesthesia and end of skin preparation | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature | Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU | Day 1 |
| Intraoperative Temperatures | Core body temperature measured intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Mraovic, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Centers for Disease Control and Prevention. The state of aging and health in America 2013. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services, 2013. | ||
| 24947647 | Background | Billeter AT, Hohmann SF, Druen D, Cannon R, Polk HC Jr. Unintentional perioperative hypothermia is associated with severe complications and high mortality in elective operations. Surgery. 2014 Nov;156(5):1245-52. doi: 10.1016/j.surg.2014.04.024. Epub 2014 Jun 16. | |
| 1642343 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Convective Pre-warming | Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming 3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming |
| FG001 | Standard of Care | Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Convective Pre-warming | Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming 3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Core Body Temperature | Change in core temperature between induction of anesthesia and end of skin preparation | Posted | Mean | Standard Deviation | Degrees Celsius | Day 1 |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Convective Pre-warming | Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming 3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming |
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Early termination due to low subject recruitment leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Boris Mraovic, Professor of Clinical Anesthesiology | University of Missouri - Columbia | 573-882-2568 | mraovicb@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2017 | Jun 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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At time of consent the randomization is masked for the participant, care provider, and investigator. Once randomization has occurred there is no masking as you clearly know what group has been assigned.
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| 3M™ Bair Paws™ Flex Gown | Device | Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming |
|
| Day 1 |
| Temperature Differences Between Different Age Groups | Differences in temperature changes between elderly (≥ 65 years) and younger patients (< 65 years). | Day 1 |
| Background |
| Frank SM, Beattie C, Christopherson R, Norris EJ, Rock P, Parker S, Kimball AW Jr. Epidural versus general anesthesia, ambient operating room temperature, and patient age as predictors of inadvertent hypothermia. Anesthesiology. 1992 Aug;77(2):252-7. doi: 10.1097/00000542-199208000-00005. |
| Background | Sessler, Daniel I. Chapter 8: preoperative thermoregulation. Geriatric Anesthesia, 2nd ed., Springer, New York, NY: 107-118, 2008. |
| 8368549 | Background | Glosten B, Hynson J, Sessler DI, McGuire J. Preanesthetic skin-surface warming reduces redistribution hypothermia caused by epidural block. Anesth Analg. 1993 Sep;77(3):488-93. doi: 10.1213/00000539-199309000-00012. |
| 8363070 | Background | Kurz A, Plattner O, Sessler DI, Huemer G, Redl G, Lackner F. The threshold for thermoregulatory vasoconstriction during nitrous oxide/isoflurane anesthesia is lower in elderly than in young patients. Anesthesiology. 1993 Sep;79(3):465-9. doi: 10.1097/00000542-199309000-00008. |
| 9141926 | Background | Ozaki M, Sessler DI, Matsukawa T, Ozaki K, Atarashi K, Negishi C, Suzuki H. The threshold for thermoregulatory vasoconstriction during nitrous oxide/sevoflurane anesthesia is reduced in the elderly. Anesth Analg. 1997 May;84(5):1029-33. doi: 10.1097/00000539-199705000-00014. |
| 16434206 | Background | Kim JY, Shinn H, Oh YJ, Hong YW, Kwak HJ, Kwak YL. The effect of skin surface warming during anesthesia preparation on preventing redistribution hypothermia in the early operative period of off-pump coronary artery bypass surgery. Eur J Cardiothorac Surg. 2006 Mar;29(3):343-7. doi: 10.1016/j.ejcts.2005.12.020. Epub 2006 Jan 24. |
| 24193180 | Background | Perl T, Peichl LH, Reyntjens K, Deblaere I, Zaballos JM, Brauer A. Efficacy of a novel prewarming system in the prevention of perioperative hypothermia. A prospective, randomized, multicenter study. Minerva Anestesiol. 2014 Apr;80(4):436-43. Epub 2013 Oct 3. |
| 22376088 | Background | 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. |
| 27687449 | Background | Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17. |
| 12719051 | Background | Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3. |
| 26571323 | Background | Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70. |
| 7879936 | Background | Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009. |
| BG001 | Standard of Care | Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| American Society of Anesthesiologists (ASA) Physical Status Classification (PS Class) | ASA PS Class 2 patients were patients with mild systemic disease, while ASA PS Class 3 patients were patients with severe systemic disease. | Count of Participants | Participants |
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| Secondary | Skin Temperature | Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU | Posted | Mean | Standard Deviation | Degrees Celsius | Day 1 |
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| Secondary | Intraoperative Temperatures | Core body temperature measured intraoperatively | Posted | Mean | Standard Deviation | Degrees Celsius | Day 1 |
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| Secondary | Temperature Differences Between Different Age Groups | Differences in temperature changes between elderly (≥ 65 years) and younger patients (< 65 years). | In the Standard of care group there were only patients aged 65 years and older. This group also did not receive prewarming aside from blankets, therefore temperature was only recorded once in the preoperative unit. | Posted | Mean | Standard Deviation | Degrees Celcius | Day 1 |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Standard of Care | Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Temperature before prewarming - Patients >65 years of age |
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| Temperature after prewarming - Patients <65 years of age |
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| Temperature after prewarming - Patients >65 years of age |
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