The Effects of Active Warming on Temperature on Core Body and Thermal Comfort
NCT ID: NCT04985617
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2019-02-08
2019-12-20
Brief Summary
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Design: This was a prospective, randomized controlled experimental study. Methods: A total of 105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia care unit. The fluids in the experimental group were warmed until the body temperature was reached 36.0°C.
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Detailed Description
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Design: This was a prospective, randomized controlled experimental study. Methods: A total of 105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia care unit. The fluids in the experimental group were warmed until the body temperature was reached 36.0°C. The intravenous (IV) fluid given to the two groups was 1000 ml of 0.9% isotonic sodium chloride solution.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Warmed Fluids
When patients recovered from the effect of anesthesia, awakened and were able to switch to normal spontaneous breathing, they were taken from the sober unit to the service or intensive care unit, and subsequent follow-ups were carried out by the researcher in these units. The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
Warmed Fluids
The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
Room Temperature Fluids
When patients recovered from the effect of anesthesia, awakened and were able to switch to normal spontaneous breathing, they were taken from the sober unit to the service or intensive care unit, and subsequent follow-ups were carried out by the researcher in these units. The IV fluid given to the patients in the control group was given at room temperature without heating and without intervention
No interventions assigned to this group
Interventions
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Warmed Fluids
The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
Eligibility Criteria
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Inclusion Criteria
* patients who were undergoing general anesthesia, to whom voluntary hypothermia was not applied during the operation,
* patients who were hemodynamically stable,
* patients who had a physician's order for 1000 ml of 0.9% Isotonic Sodium Chloride IV fluid treatment,
* patients were undergoing bladder irrigation were included in the study.
* patients the sense, expression of heat by the patient in recovery,
* patient who accepted to participate to the study
Exclusion Criteria
* patients have underlying diseases (hypothyroidism, hyperthyroidism, diabetes, cardiovascular disease or kidney failure)
* patients who had mental deficiency that could prevent communication,
* patients who had visual or hearing impairments,
* patients who were receiving mechanical ventilation support, were sedated,
* patients were the need for open surgery or any reason for returning the patient to the operating room,
* patients need for postoperative blood transfusions,
* patients have intra-abdominal infection,
* patients have an unexpected allergy to anesthetic drugs,
* patients have a temperature higher than 36.0ºC,
* patients have for cardiopulmonary resuscitation,
* patients have severe hemodynamic changes during the operation.
37 Years
90 Years
MALE
No
Sponsors
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Ege University
OTHER
Responsible Party
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HÜLYA YILMAZ, PhD
Principal Investigator, Msc, PhD Hülya YILMAZ
Locations
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Ege University Health Sciences Institute
Izmir, Bornova, Turkey (Türkiye)
Countries
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References
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Xu HX, You ZJ, Zhang H, Li Z. Prevention of hypothermia by infusion of warm fluid during abdominal surgery. J Perianesth Nurs. 2010 Dec;25(6):366-70. doi: 10.1016/j.jopan.2010.10.007.
Woolnough M, Allam J, Hemingway C, Cox M, Yentis SM. Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial. Int J Obstet Anesth. 2009 Oct;18(4):346-51. doi: 10.1016/j.ijoa.2009.02.009. Epub 2009 Aug 7.
Chung SH, Lee BS, Yang HJ, Kweon KS, Kim HH, Song J, Shin DW. Effect of preoperative warming during cesarean section under spinal anesthesia. Korean J Anesthesiol. 2012 May;62(5):454-60. doi: 10.4097/kjae.2012.62.5.454. Epub 2012 May 24.
Related Links
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Prevention of hypothermia by infusion of warm fluid during abdominal surgery
Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial
Effect of preoperative warming during cesarean section under spinal anesthesia.
Other Identifiers
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08/02/2019- E.43649
Identifier Type: -
Identifier Source: org_study_id
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