The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Clinical Trial Evaluating the Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities in Patients Enrolled in the TIGER Anesthesia Perioperative Protocol

Conditions
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Temperature Change, Body

Intervention / Treatment
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* Device: Bair Hugger™ Temperature Management Unit Model 750
* Device: 3M™ Bair Paws™ Flex Gown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-IV Other inclusion criteria as delineated in the TIGER anesthesia perioperative protocol Exclusion Criteria: Inability to obtain written informed consent Inability to obtain core body temperature recordings Family history of malignant hyperthermia Preoperative temperature > 38° C Other exclusion criteria as delineated in the TIGER anesthesia perioperative protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convective pre-warming<br>Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room | Device: Bair Hugger™ Temperature Management Unit Model 750<br>* Forced-air temperature management unit used for preoperative and intraoperative participant warming<br>Device: 3M™ Bair Paws™ Flex Gown<br>* Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming<br>|
| No Intervention: Standard of care<br>Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core Body Temperature | Change in core temperature between induction of anesthesia and end of skin preparation | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Day 1 | 
| Temperature Differences Between Different Age Groups | Differences in temperature changes between elderly (≥ 65 years) and younger patients (< 65 years). | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temperature, prewarming, convective warming, thermoregulation, gastrointestinal surgery, genitourinary surgery