Postoperative HypothermiaNCT04985617
The Effects of Active Warming on Temperature on Core Body and Thermal Comfort
A study testing Warmed Fluids in people with Postoperative Hypothermia and Thermal Comfort, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 37 to 90 years, men only
- Conditions the study is for
- Postoperative Hypothermia, Thermal Comfort, Body Temperature Changes
- What is being tested?
- Warmed Fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Health Sciences Institute
Izmir, Bornova, 35100
About this study
Official title: The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate
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.
Read the 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.
- Being tested
- Warmed Fluids
- Keywords
- fluid infusion, postoperative hypothermia, nursing, active warming
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed FluidsOther
The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
| Study group | Role | What they receive |
|---|---|---|
| Warmed Fluids | Experimental | 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. Receives: Other: Warmed Fluids |
| Room Temperature Fluids | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start8 Feb 2019
- Primary completion30 Jul 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative HypothermiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜLYA YILMAZ, PhD, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985617
- Sponsor's protocol ID
- 08/02/2019- E.43649
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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".
Publications
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.
PubMed 21126666Woolnough 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.
PubMed 19665366Chung 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.
PubMed 22679543
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate
- ClinicalTrials.gov ID
- NCT04985617
- Acronym / sponsor ID
- 08/02/2019- E.43649
- Keywords
- fluid infusion, postoperative hypothermia, nursing, active warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a prospective, randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Warmed Fluids | Experimental | Other: Warmed FluidsWhen 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. |
| Room Temperature Fluids | No intervention | –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 |
Who may qualify
- Ages
- 37 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warmed FluidsThe IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device. | Other | Warmed Fluids |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 21126666Xu 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.
- Background: PubMed 19665366Woolnough 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.
- Background: PubMed 22679543Chung 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.
- Prevention of hypothermia by infusion of warm fluid during abdominal surgeryLink provided by the sponsor.
- Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trialLink provided by the sponsor.
- Effect of preoperative warming during cesarean section under spinal anesthesia.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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".
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed Fluids in people with Postoperative Hypothermia and Thermal Comfort, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal Comfort Scale (TCS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.