Clinical trial NCT04985617: The Effects of Active Warming on Temperature on Core Body and Thermal Comfort
Official title: The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Hypothermia
Thermal Comfort
Body Temperature Changes
Keywords: fluid infusion
postoperative hypothermia
nursing
active warming
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 105
Sex: MALE
Minimum age (years): 37
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective, randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF) on the core body temperature and the patients' thermal comforts during the postoperative period in patients undergoing transurethral resection of the prostate (TURP).

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.

Detailed description: Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF) on the core body temperature and the patients' thermal comforts during the postoperative period in patients undergoing transurethral resection of the prostate (TURP).

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.

Eligibility criteria: Inclusion Criteria:

* patients who age bigger than18,
* 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 any infection, fever
* 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.

Primary outcomes:
measure: Thermal Comfort Scale (TCS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Health Sciences Institute
state: Bornova
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.