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

E

Ege University

Status

Completed

Conditions

Body Temperature Changes
Thermal Comfort
Postoperative Hypothermia

Treatments

Other: Warmed Fluids

Study type

Interventional

Funder types

Other

Identifiers

NCT04985617
08/02/2019- E.43649

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

Male

Ages

37 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Warmed Fluids
Experimental group
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.
Treatment:
Other: Warmed Fluids
Room Temperature Fluids
No Intervention group
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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