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Bedah 1
Bedah 1
Bedah 1
Original Contribution
Department of Anesthesiology and Critical Care, University Hospital Marburg and Medical Faculty, Philipps-University of
Marburg, Germany
b
Department Cardiovascular Sciences and Department of Anesthesiology, KU Leuven, University Hospitals Leuven, Belgium
c
Department of Operative and Intensive Care, Hallands sjukhus Varberg, Sweden
d
Department of Orthopedics, Aleris Specialistvrd, Motala Hospital, Sweden
e
Department of Anesthesiology, Oslo University Hospital and Medical Faculty, University of Oslo, Norway
Received 28 August 2015; revised 3 June 2016; accepted 7 June 2016
Keywords:
Perioperative hypothermia;
Guideline on surgical patient
thermal management;
Prewarming;
Self-warming blanket
Abstract
Study Objective: Incidence of inadvertent perioperative hypothermia is still high; therefore, present guidelines advocate prewarming for its prevention. Prewarming means preoperative patient skin warming,
which minimizes redistribution hypothermia caused by induction of anesthesia. In this study, we compared
the new self-warming BARRIER EasyWarm blanket with passive thermal insulation regarding mean perioperative patient core body temperature.
Design: Multinational, multicenter randomized prospective open-label controlled trial.
Setting: Surgical ward, operation room, postanesthesia care unit at 4 European hospitals.
Patients: A total of 246 adult patients, American Society of Anesthesiologists class I to III undergoing
elective orthopedic; gynecologic; or ear, nose, and throat surgery scheduled for 30 to 120 minutes under
general anesthesia.
Interventions: Patients received warmed hospital cotton blankets (passive thermal insulation, control
group) or BARRIER EasyWarm blanket at least 30 minutes before induction of general anesthesia and
throughout the perioperative period (intervention group).
Disclosure: The clinical trial was supported by Mlnlycke Health Care AB, Gothenburg, Sweden.
Correspondence: Alexander Torossian, MD, Department of Anesthesiology and Critical Care, University Hospital Marburg, Baldinger Str 1, 34033 Marburg,
Germany. Tel.: +49 6421 5869864; fax: +49 6421 5866996.
E-mail address: alexander.torossian@med.uni-marburg.de (A. Torossian).
1
Authors contributed equally to the manuscript.
http://dx.doi.org/10.1016/j.jclinane.2016.06.030
0952-8180/ 2016 . Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
548
A. Torossian et al.
Measurements: The primary efcacy outcome was the perioperative mean core body temperature measured
by a tympanic infrared thermometer. Secondary outcomes were hypothermia incidence, change in core body
temperature, length of stay in postanesthesia care unit, thermal comfort, patient satisfaction, ease of use, and
adverse events related to the BARRIER EasyWarm blanket.
Main Results: The BARRIER EasyWarm blanket signicantly improved perioperative core body temperature compared with standard hospital blankets (36.5C, SD 0.4C, vs 36.3, SD 0.3C; P b .001). Intraoperatively, in the intervention group, hypothermia incidence was 38% compared with 60% in the control group
(P = .001). Postoperatively, the gures were 24% vs 49%, respectively (P = .001). Patients in the intervention group had signicantly higher thermal comfort scores, preoperatively and postoperatively. No serious
adverse effects were observed in either group.
Conclusions: Perioperative use of the new self-warming blanket improves mean perioperative core body
temperature, reduces the incidence of inadvertent perioperative hypothermia, and improves patients' thermal
comfort during elective adult surgery.
2016 . Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
Perioperative hypothermia is dened as a patient core temperature less than 36C. Incidence of postoperative hypothermia in elective surgery is reported to be 26% to 90% [1].
However, it is a preventable anesthesia- and surgery-related
complication that affects patients' outcome. Specically, hypothermia is associated with an increased risk of surgical site
infections, bleeding, postoperative shivering, and cardiovascular complications [2-5]. Despite overwhelming evidence, a
survey in 16 European countries on intraoperative patient temperature management revealed that only 40% of patients under
general anesthesia were warmed and 20% were perioperatively monitored with respect to body temperature [6]. Under
regional anesthesia, 28% of patients were warmed, and 6%
had their temperature taken. Unsurprisingly, such inferior surgical patient thermal management may negatively impact not
only patient outcome including patient satisfaction but also total hospital treatment costs [7,8,9].
Recently, the German S3 guideline on Prevention of Inadvertent Perioperative Hypothermia has been published [8]. In
Germany, clinical guideline development is governed by the
Association of the Scientic Medical Societies (AWMF").
S3 labels the highest guideline standard, which combines the
best available level of evidence with formal consensus. In contrast
to the older National Institute for Health and Care Excellence, UK
guideline CG65 [9], prewarming as a preventive strategy in
surgical patients' thermal management is now strongly recommended and supported by high-level evidence [10,11].
Prewarming means warming patients' skin and peripheral
tissues before induction of anesthesia, which decreases the
central-to-peripheral temperature gradient. Consequently, core
heat loss which results from thermal redistribution after the onset of anesthesia can be minimized [12].
Several devices, for example, convective or conductive, are
available to actively prewarm surgical patients; however, all depend on external electrical sources [13]. In contrast, the new
BARRIER EasyWarm blanket (Mlnlycke Health Care AB,
Gothenburg, Sweden) is a disposable, self-warming device.
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experiencing hypothermia perioperatively, the change in patient temperature from the preoperative to the postoperative
period, thermal comfort of patients, patient overall satisfaction,
and length of stay in PACU.
550
A. Torossian et al.
3. Results
A total of 277 patients were screened, and nally, 246 completed the study (122 in the treatment group and 124 in the
control group, Fig. 1). No site accounted for more than 30%
of the subjects enrolled.
Dropout reasons were canceled surgery, patient prewarmed
with the BARRIER EasyWarm for less than 30 minutes, missing more than 1 temperature point registration, ear not accessible for measurement during surgery, use of rescue warming
when temperature was not less than 35.5C, patient with preoperative thyroxine medication, duration of surgery less than
30 minutes, and device problems.
Demographic data (sex, age, height, weight, ASA score,
and body mass index) and type or length of surgical procedure
were comparable in both groups (Table 1).
Screened
n=277
Screening failure
n=6
Eligible to be
randomised
n=271
Randomised to
Interventional Treatment
(ITT)
Randomised to
Control Treatment
(ITT)
n=134
n=137
Early
discontinuation
n=12
Early
discontinuation
n=13
n=122
n=124
Fig. 1
551
30/92
46.5 15.3
28/96
45.6 14.8
NA
26.8 4.4
25.1 4.3
NA
25.7 2.6
25.4 5.1
68 (55.7%)
53 (43.4%)
1 (0.8%)
53.2 34.4 (5-160)
69 (55.6%)
54 (43.5%)
1 (0.8%)
56.0 32.5 (3-160)
50 (41.0%)
56 (45.9%)
16 (13.1%)
57 (46.0%)
59 (47.6%)
8 (6.5%)
ASA PS = American Society of Anesthesiologists physical status classication system; BMI = body mass index; ENT = ear, nose, and throat surgery; NA =
not available/not applicable.
Mean, SD, and percentage values rounded to 1 decimal place.
Perioperative period
Mean SD
Min-max
36.52 0.37
35.42-37.37
36.34 0.34
35.51-37.37
b.001
Preoperative period
Mean SD
Min-max
36.86 0.33
35.80-37.62
36.79 0.29
36.03-37.65
NA
Intraoperative period
Mean SD
Min-max
36.45 0.41
35.26-37.46
36.25 0.38
35.31-37.39
b.001
Postoperative period
Mean SD
Min-max
36.27 0.47
34.93-37.43
36.00 0.46
35.00-37.27
b.001
Mean and SD values rounded to 2 decimal places. P values are results of 2-tailed, independent-samples t tests.
552
Table 3
A. Torossian et al.
Incidence of hypothermic patients (b36C)
Intervention group (n = 122)
Perioperative period
Hypothermic subjects, n (%)
Normothermic subjects, n (%)
All subjects, n (%)
53 (43.4%)
69 (56.6%)
122 (100.0%)
84 (67.7%)
40 (32.3%)
124 (100.0%)
b.001
Preoperative period
Hypothermic subjects, n (%)
Normothermic subjects, n (%)
All subjects, n (%)
3 (2.5%)
119 (97.5%)
122 (100.0%)
1 (0.8%)
123 (99.2%)
124 (100.0%)
.747
Intraoperative period
Hypothermic subjects, n (%)
Normothermic subjects, n (%)
All subjects, n (%)
46 (37.7%)
76 (62.3%)
122 (100.0%)
75 (60.5%)
49 (39.5)
124 (100.0%)
.001
Postoperative period
Hypothermic subjects, n (%)
Normothermic subjects, n (%)
All subjects, n (%)
29 (23.8%)
93 (76.2%)
122 (100.0%)
61 (49.2%)
63 (50.8%)
124 (100.0%)
.001
Percentage values are rounded to 1 decimal place. P values are results of Fisher exact tests.
4. Discussion
This open-label, randomized controlled multicenter study
showed that prewarming surgical patients with the new
BARRIER EasyWarm blanket for 30 minutes improves patients' mean core body temperature throughout the perioperative period.
This result is in line with a Cochrane review on surgical patient warming which demonstrated that forced-air warming increases postoperative core body temperature compared with
thermal insulation, although the authors stated that the impact
on patient outcome, for example, on surgical site infections, remains to be proven [15].
Absolute increase in body temperature by the intervention
was 0.3C in our study, which may be criticized not being clinically relevant. However, we regard the signicant decrease of
the incidence of intraoperative and postoperative hypothermia
using BARRIER EasyWarm blanket for prewarming to be
Table 4
Preoperative period
Mean SD
Min-max
36.86 0.33
35.80-37.62
36.79 0.29
36.03-37.65
NA
NA
Postoperative period
Mean SD
Min-max
36.27 0.47
34.93-37.43
36.00 0.46
35.00-37.27
b.001
NA
Difference (post-pre)
Mean SD
0.59 0.42
0.79 0.43
b.001
Mean and SD values are rounded to 2 decimal places. P value is the result of a 2-tailed, independent-samples t test.
553
N20.5C
19.5C-20.5C
b19.5C
Admittance to preoperative
(n = 246)
222
14
10
90.2
5.7
4.1
245
1
0
99.6
0.4
0.0
Patients' thermal comfort levels, overall satisfaction, and length of stay in PACU
Intervention group
Control group
108.22
60.41
61.63
88.20
116.69
51.78
52.90
87.35
.320
b.001
b.001
.648
57.31
10.21
14.14
13.60
74.97
11.47
12.82
13.87
Mean and SD values are rounded to 2 decimal places. P values are results of 2-tailed, independent-samples t tests or Fisher exact tests as appropriate.
554
may assume that all bias was equally distributed between
groups and participating centers.
5. Conclusion
In summary, we could show feasibility of the prewarming
concept using a new self-warming blanket. In our hands, prewarming the patient with the novel BARRIER EasyWarm
blanket 30 minutes before anesthesia reduced the risk of perioperative hypothermia compared to thermal insulation with
standard hospital cotton blankets and resulted in improved patient thermal comfort without any severe adverse effects.
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