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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03876808
Enrollment
10
Registered
2019-03-15
Start date
2017-10-26
Completion date
2018-11-07
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temperature Change, Body

Keywords

temperature, prewarming, convective warming, thermoregulation, gastrointestinal surgery, genitourinary surgery

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.

Interventions

DEVICEBair Hugger™ Temperature Management Unit Model 750

Forced-air temperature management unit used for preoperative and intraoperative participant warming

DEVICE3M™ Bair Paws™ Flex Gown

Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Core Body TemperatureDay 1Change in core temperature between induction of anesthesia and end of skin preparation

Secondary

MeasureTime frameDescription
Skin TemperatureDay 1Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU
Intraoperative TemperaturesDay 1Core body temperature measured intraoperatively
Temperature Differences Between Different Age GroupsDay 1Differences in temperature changes between elderly (≥ 65 years) and younger patients (\< 65 years).

Countries

United States

Participant flow

Participants by arm

ArmCount
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
6
Standard of Care
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
4
Total10

Baseline characteristics

CharacteristicConvective Pre-warmingTotalStandard of Care
Age, Continuous59.8 years
STANDARD_DEVIATION 19
63.7 years
STANDARD_DEVIATION 15.1
69.5 years
STANDARD_DEVIATION 2.4
American Society of Anesthesiologists (ASA) Physical Status Classification (PS Class)
ASA PS Class 2
4 Participants7 Participants3 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification (PS Class)
ASA PS Class 3
2 Participants3 Participants1 Participants
Body Mass Index (BMI)30 kg/m^2
STANDARD_DEVIATION 5.7
30.9 kg/m^2
STANDARD_DEVIATION 8.5
33.7 kg/m^2
STANDARD_DEVIATION 12.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants10 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants10 Participants4 Participants
Region of Enrollment
United States
6 participants10 participants4 participants
Sex: Female, Male
Female
1 Participants1 Participants0 Participants
Sex: Female, Male
Male
5 Participants9 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 4
other
Total, other adverse events
0 / 60 / 4
serious
Total, serious adverse events
0 / 60 / 4

Outcome results

Primary

Core Body Temperature

Change in core temperature between induction of anesthesia and end of skin preparation

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Convective Pre-warmingCore Body Temperature-0.95 Degrees CelsiusStandard Deviation 0.69
Standard of CareCore Body Temperature-0.53 Degrees CelsiusStandard Deviation 0.85
Secondary

Intraoperative Temperatures

Core body temperature measured intraoperatively

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Convective Pre-warmingIntraoperative Temperatures36.0 Degrees CelsiusStandard Deviation 0.79
Standard of CareIntraoperative Temperatures35.7 Degrees CelsiusStandard Deviation 0.17
Secondary

Skin Temperature

Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU

Time frame: Day 1

ArmMeasureGroupValue (MEAN)Dispersion
Convective Pre-warmingSkin TemperatureHolding area to operating room departure-0.03 Degrees CelsiusStandard Deviation 0.39
Convective Pre-warmingSkin TemperatureHolding area to arrival in PACU-0.07 Degrees CelsiusStandard Deviation 0.67
Standard of CareSkin TemperatureHolding area to operating room departure0.08 Degrees CelsiusStandard Deviation 0.42
Standard of CareSkin TemperatureHolding area to arrival in PACU-0.48 Degrees CelsiusStandard Deviation 0.56
Secondary

Temperature Differences Between Different Age Groups

Differences in temperature changes between elderly (≥ 65 years) and younger patients (\< 65 years).

Time frame: Day 1

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Convective Pre-warmingTemperature Differences Between Different Age GroupsTemperature before prewarming - Patients <65 years of age36.5 Degrees CelciusStandard Deviation 0.2
Convective Pre-warmingTemperature Differences Between Different Age GroupsTemperature before prewarming - Patients >65 years of age36.6 Degrees CelciusStandard Deviation 0.6
Convective Pre-warmingTemperature Differences Between Different Age GroupsTemperature after prewarming - Patients <65 years of age36.5 Degrees CelciusStandard Deviation 0.3
Convective Pre-warmingTemperature Differences Between Different Age GroupsTemperature after prewarming - Patients >65 years of age36.4 Degrees CelciusStandard Deviation 0.5
Standard of CareTemperature Differences Between Different Age GroupsTemperature before prewarming - Patients >65 years of age36.5 Degrees CelciusStandard Deviation 0.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026