UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053127 |
|---|---|
| Receipt number | R000060628 |
| Scientific Title | Effect of Short-Time Prewarming Using a Conductive Polymer Warming Device in General Anesthetic Patients |
| Date of disclosure of the study information | 2024/12/19 |
| Last modified on | 2025/12/16 14:04:10 |
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Basic information
Public title
Effect of Short-Time Prewarming Using a Conductive Polymer Warming Device in General Anesthetic Patients
Acronym
Effectiveness of short-time prewarming
Scientific Title
Effect of Short-Time Prewarming Using a Conductive Polymer Warming Device in General Anesthetic Patients
Scientific Title:Acronym
Effectiveness of short-time prewarming
Region
| Japan |
Condition
Condition
Colon
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify the effectiveness of short-time prewarming with a conductive polymer heating device in general anesthesia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central temperature
Key secondary outcomes
Skin temperature, Difference between central temperature and skin temperature, Decrease in central temperature up to 30 min after injection of sedative
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After recumbency on the operating table, prewarming of the upper and lower limb periphery is performed.
Interventions/Control_2
After bed rest on the operating table, prewarming of the upper and lower extremities is not performed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: 20 years or older
Gender: Unacceptable
Operative method: Laparoscopic surgery
Surgical site: Lower GI surgery
ASA classification: 1 -3
Preoperative preparation: Patients with an infusion route placed at the time of admission to the operating room
Anesthesia: A Case of General Anesthesia
After receiving sufficient explanation for participation in this study, the patient's free written consent was obtained with sufficient understanding.
Key exclusion criteria
emergency surgery
Patients with a family history of malignant hyperthermia
Patients with allergic or other drug hypersensitivity
Other patients judged by the research director to be unsuitable as research subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
856-8562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81-957-52-3121
haraken1124@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
856-8562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81-957-52-3121
Homepage URL
haraken1124@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagasaki Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Nagasaki Medical Center Ethics Review Committee
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
Tel
+81-957-52-3121
haraken1124@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
90
Results
This randomized controlled trial demonstrated that adding a 5-minute limb-focused prewarming protocol to standard whole-body prewarming significantly attenuated redistribution hypothermia. The intervention group showed a significantly higher core temperature at 30 minutes after anesthesia induction and a smaller decline from baseline. Peripheral skin temperature and perfusion index were also significantly higher at multiple peri-induction time points.
Results date posted
| 2025 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 82 participants were analyzed (41 in the intervention group and 41 in the control group). There were no significant differences between groups in age, sex, height, weight, body mass index, ASA physical status, comorbidities (hypertension, diabetes mellitus, ischemic heart disease), or preoperative laboratory values (total protein, albumin, hemoglobin).
Participant flow
Of 90 eligible patients, 82 were randomized and included in the analysis. Eight patients were excluded prior to randomization due to emergency surgery (n=4) or refusal to participate (n=4). No participants were lost after randomization, and all randomized patients were included in the primary outcome analysis.
Adverse events
No adverse events related to the intervention were observed.
Outcome measures
The primary outcome was core temperature at 30 minutes after anesthesia induction.
Secondary outcomes included peripheral skin temperature, perfusion index, and the change in core temperature from baseline.
Plan to share IPD
No.
IPD sharing Plan description
There is no plan to share individual participant data.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060628
