The Effects of Active Warming on Temperature on Core Body and Thermal Comfort

Body Temperature Changes Clinical Trial

Official title:

The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985617
• Other study ID #: 08/02/2019- E.43649
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: July 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 20, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 37 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Postoperative Hypothermia
• Thermal Comfort

Intervention

Other:
• Warmed Fluids
The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.

Locations

Country	Name	City	State
Turkey	Ege University Health Sciences Institute	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal Comfort Scale (TCS)	Thermal Comfort Scale (TCS): This is a Likert type scale which was developed by Wagner et. al. (2006) and the validity and reliability in Turkish was tested by Özsaban (2017). The evaluation of thermal comfort was made by the face to face interview method for all patients. The TCS evaluates the patient's temperature comfort perception subjectively. The scale consists of 13 items in total, and each item is scored between 1 and 6 points. A high score indicates a high temperature comfort level.	6 months

External Links

•   Effect of preoperative warming during cesarean section under spinal anesthesia.
•   Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial
•   Prevention of hypothermia by infusion of warm fluid during abdominal surgery