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

NCT04985617 | Completed

• 1 other identifier: 08/02/2019- E.43649
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hypothermia; Thermal Comfort; Body Temperature Changes

Keywords

fluid infusion; postoperative hypothermia; nursing; active warming

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Warmed Fluids

EXPERIMENTAL

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.

Other: Warmed Fluids

Room Temperature Fluids

NO INTERVENTION

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

Interventions

Warmed Fluids OTHER

The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.

Warmed Fluids

Eligibility Criteria

• Age: 37 Years - 90 Years
• Gender Eligibility Details: Bening prostatic hyperplasia (BPH) is a histopathological condition requiring surgical intervention in men over 60 years of age due to the increase or proliferation of epithelial and stromal tissues of the prostate around the urethra (Dirim, 2010; Gilroy, 2015).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Health Sciences Institute

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 21126666 BACKGROUND

• 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.

  PMID: 19665366 BACKGROUND

• 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.

  PMID: 22679543 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The intervention and measurements were carried out by the first researcher, and the patients discovered their own groups when the postoperative warming intervention was applied to them. Because of the nature of the intervention, blinding could not be performed
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Msc, PhD Hülya YILMAZ

Model Details: This was a prospective, randomized controlled experimental study.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 2, 2021
• Study Start: February 8, 2019
• Primary Completion: July 30, 2019
• Study Completion: December 20, 2019
• Last Updated: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6months
• Access Criteria: Active Warming on Temperature on Core Body and Thermal Comfort in Patients

Locations

TU (1)