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

NCT ID: NCT04985617

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2019-12-20

Brief Summary

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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

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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.

Conditions

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Postoperative Hypothermia Thermal Comfort Body Temperature Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a prospective, randomized controlled experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Warmed Fluids

Intervention Type OTHER

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

Room Temperature 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 control group was given at room temperature without heating and without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Warmed Fluids

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

37 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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HÜLYA YILMAZ, PhD

Principal Investigator, Msc, PhD Hülya YILMAZ

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University Health Sciences Institute

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21126666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19665366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22679543 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.jopan.2010.10.007

Prevention of hypothermia by infusion of warm fluid during abdominal surgery

http://doi.org/10.1016/j.ijoa.2009.02.009

Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial

http://doi.org/10.4097/kjae.2012.62.5.454

Effect of preoperative warming during cesarean section under spinal anesthesia.

Other Identifiers

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08/02/2019- E.43649

Identifier Type: -

Identifier Source: org_study_id

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