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

Primary Purpose

Postoperative Hypothermia, Thermal Comfort, Body Temperature Changes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Warmed Fluids
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Hypothermia focused on measuring fluid infusion, postoperative hypothermia, nursing, active warming

Eligibility Criteria

37 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ege University Health Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Warmed Fluids

Room Temperature Fluids

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2021
Last Updated
August 2, 2021
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04985617
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hypothermia, Thermal Comfort, Body Temperature Changes
Keywords
fluid infusion, postoperative hypothermia, nursing, active warming

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a prospective, randomized controlled experimental study.
Masking
None (Open Label)
Masking Description
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
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warmed Fluids
Arm Type
Experimental
Arm Description
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.
Arm Title
Room Temperature Fluids
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Warmed Fluids
Intervention Description
The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
Primary Outcome Measure Information:
Title
Thermal Comfort Scale (TCS)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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).
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ege University Health Sciences Institute
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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, and the IV fluid given to the patients in the control group was given at room temperature without heating. The environment temperature of the room was the same in the service, intensive care, and recovery units on the same day. The environment temperature of the room varied between 20ºC and 25ºC on the different days on which the research was implemented. The air humidity level was between 32% and 45%. Body temperature was measured as soon as the infusion started and was repeated every 60 minutes using a "tympanic thermometer".
IPD Sharing Time Frame
6months
IPD Sharing Access Criteria
Active Warming on Temperature on Core Body and Thermal Comfort in Patients
Citations:
PubMed Identifier
21126666
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.
Results Reference
background
PubMed Identifier
19665366
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.
Results Reference
background
PubMed Identifier
22679543
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.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.jopan.2010.10.007
Description
Prevention of hypothermia by infusion of warm fluid during abdominal surgery
URL
http://doi.org/10.1016/j.ijoa.2009.02.009
Description
Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial
URL
http://doi.org/10.4097/kjae.2012.62.5.454
Description
Effect of preoperative warming during cesarean section under spinal anesthesia.

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

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