UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059268 |
|---|---|
| Receipt number | R000067790 |
| Scientific Title | Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/07 |
| Last modified on | 2025/10/02 15:16:41 |
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Basic information
Public title
Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial
Acronym
Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial
Scientific Title
Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial
Scientific Title:Acronym
Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Robot-assisted pulmonary resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the superiority of ward-initiated prewarming compared with operating room-initiated prewarming.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core-to-peripheral body temperature gradient at anesthesia induction.
Key secondary outcomes
1, Changes in core body temperature during the first hour after anesthesia induction.
2, Perioperative changes in core body temperature, peripheral body temperature, and the core-to-peripheral body temperature gradient.
3, Incidence and number of postoperative complications related to body temperature.
4, Preoperative subjective cold sensation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Intervention group
Before entering the operating room, participants will have roll-up stockinette (SIGMAX) applied to all limbs in the ward, followed by whole-body warming with an electric blanket (TEKNOS, EM-713M) set at 'medium' (35 +/- 5C) for 15-20 minutes.
Interventions/Control_2
Control group
No prewarming will be performed in the ward.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Patients aged 65 years or older at the time of informed consent.
2, Patients scheduled to undergo robot-assisted pulmonary resection (RATS) under general anesthesia.
3, Patients who have provided informed consent to participate in this study.
Key exclusion criteria
1, Patients younger than 65 years.
2, Patients with implanted medical electrical devices such as a pacemaker, or those who have difficulty maintaining a standing position or holding measurement instruments.
3, Patients with neurological symptoms such as paralysis or sensory impairment.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Sakamoto |
Organization
Fukushima Medical University
Division name
Department of Adult and Gerontological Nursing
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
TEL
024-547-1861
ysakamo@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Graduate School of Nursing, Fukushima Medical University
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
TEL
024-547-1111
Homepage URL
dn246501@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
KIMURA FOUNDATION FOR NURSING EDUCATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee Section, Division of Medical Research Promotion, Administrative Office, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
Tel
024-547-1825
rs@fmu.ac.jp
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
| 2025 | Year | 10 | Month | 07 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067790
