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NCT Number: NCT04985617

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

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.

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Key information

Age range

37 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Health Sciences Institute

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warmed Fluids

Other

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

Primary outcomes

  1. Thermal Comfort Scale (TCS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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