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

Not Applicable

Completed

• Conditions: Body Temperature Changes; Thermal Comfort; Postoperative Hypothermia
• Interventions: Other: Warmed Fluids

• Registration Number: NCT04985617
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2019-02-08
• Primary Completion: 2019-07-30
• Study Completion: 2019-12-20
• Status Verified: 2021-07
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-02
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warmed Fluids	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.

Primary Outcome Measures

Name	Time	Method
Thermal Comfort Scale (TCS)	6 months	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.

Trial Locations

Locations (1)

Ege University Health Sciences Institute; 🇹🇷 İzmir, Bornova, Turkey