Urologic DiseasesNCT04991272
10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature
A study testing prewarming and warmed fluid infusion in people with Urologic Diseases, run by Inje University at 1 site in South Korea.
Trial summary
Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- prewarming and warmed fluid infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 25 Aug 2022
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing urologic surgery(transurethral resection of bladder, prostate)
Who cannot join
- moderate to severe cardiopulmonary, renal impairment
- thyroid disease
- any infection sign
- abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C)
- refusal to participate in the study
- unable to understand the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia
Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.
Read the detailed description
During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.
Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.
Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.
- Conditions
- Urologic Diseases
- Being tested
- prewarming and warmed fluid infusion
- Keywords
- hypothermia
- Medical subject headings
- Urologic Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prewarming and warmed fluid infusionOther
prewarming with forced air warming system and warmed fluid infusion.
| Study group | Role | What they receive |
|---|---|---|
| warming group | Active comparator | Warming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation. Receives: Other: prewarming and warmed fluid infusion |
| no warming group | No intervention | No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypothermia at the end of the operation
after completion of the operation, number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.
Measured: approximately 1-2hours after induction (at the end of operation)
Secondary outcomes (3)
change in temperature before and end of operation
change in core temperature will be calculated and compared
Measured: on arrival at the OR upto 1-2hours after induction (at the end of the operation)
incidence of shivering
shivering will be evaluated using 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body)
Measured: upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
thermal comfort
thermal comfort will be evaluated using thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable)
Measured: upto 1hour after end of the operation (at discharge of postanesthesia care unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jul 2021
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jung Jun, Inje University
- Investigators
- In-Jung Jun, MD. PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991272
- Sponsor's protocol ID
- 2021-05-004
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04991272
- Acronym / sponsor ID
- 2021-05-004
- Conditions
- Urologic Diseases
- Keywords
- hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 5 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.
Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.
Detailed description
During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.
Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.
Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warming group | Active comparator | Other: prewarming and warmed fluid infusionWarming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation. |
| no warming group | No intervention | –No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing urologic surgery(transurethral resection of bladder, prostate)
Key exclusion criteria (6 listed)
- moderate to severe cardiopulmonary, renal impairment
- thyroid disease
- any infection sign
- abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C)
- refusal to participate in the study
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 |
|---|---|---|
| prewarming and warmed fluid infusionprewarming with forced air warming system and warmed fluid infusion. | Other | warming group |
Primary outcome
incidence of hypothermia at the end of the operation
Time frame: approximately 1-2hours after induction (at the end of operation)
after completion of the operation, number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.
3 secondary outcomes
change in temperature before and end of operation
Time frame: on arrival at the OR upto 1-2hours after induction (at the end of the operation)
incidence of shivering
Time frame: upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
thermal comfort
Time frame: upto 1hour after end of the operation (at discharge of postanesthesia care unit)
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 25 Nov 2022.
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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.
In-Jung Jun, MD. PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prewarming and warmed fluid infusion in people with Urologic Diseases, run by Inje University at 1 site in South Korea.
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 1 inclusion and 6 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 25 Nov 2022. 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 South Korea. 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?
incidence of hypothermia at the end of the operation (time frame: approximately 1-2hours after induction (at the end of operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.