Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059268) titled 'Development of Effective Prewarming Care for Surgical Patients Aged 65 Years and Older: A Randomized Controlled Trial' on Oct. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Fukushima Medical University
Condition:
Condition - Robot-assisted pulmonary resection
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the superiority of ward-initiated prewarming compared with operating room-initiated prewarming.
Basic objectives2 - Efficacy
Intervention:
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.
Eligibility:
Age-lower limit - 65
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 Size - 38
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067790
Disclaimer: Curated by HT Syndication.