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

Not Applicable

Terminated

Conditions: Temperature Change, Body

Interventions: Device: Bair Hugger™ Temperature Management Unit Model 750
Device: 3M™ Bair Paws™ Flex Gown

Registration Number: NCT03876808

Lead Sponsor: University of Missouri-Columbia

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convective pre-warming	Bair Hugger™ Temperature Management Unit Model 750	Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Convective pre-warming	3M™ Bair Paws™ Flex Gown	Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room

Primary Outcome Measures

Name	Time	Method
Core Body Temperature	Day 1	Change in core temperature between induction of anesthesia and end of skin preparation

Secondary Outcome Measures

Name	Time	Method
Intraoperative Temperatures	Day 1	Core body temperature measured intraoperatively
Temperature Differences Between Different Age Groups	Day 1	Differences in temperature changes between elderly (≥ 65 years) and younger patients (\< 65 years).
Skin Temperature	Day 1	Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU