Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060785) titled 'Impact of Information Provision regarding PICS using ICU Diaries and
Grip Strength Charts on Physical Function in Post-Cardiac Surgery Patients' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Nagoya City University
Condition:
Condition - Post-intensive care syndrome , Patients after cardiac surgery, Physical functional decline, Motivation for rehabilitation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - A combined intervention will be implemented for cardiac surgery patients, comprising preoperative information provision regarding PICS alongside feedback during ICU stay using ICU diaries and grip strength progression charts. This exploratory study will investigate the feasibility of the intervention and its effects on postoperative physical function and rehabilitation motivation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A combined nursing intervention for cardiac surgery patients was implemented, consisting of 1) preoperative education on PICS using pamphlets, 2) the use of ICU diaries (recording clinical progress and patient comments) during the ICU stay, and 3) visual feedback provided by charting handgrip strength measurements during rehabilitation.
Eligibility:
Age-lower limit - 18
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Adult patients aged 18years or older.
Patients undergoing elective cardiac surgery.
Patients requiring the use of cardiopulmonary bypass during surgery.
Patients staying in the ICU for 48hours or more postoperatively.
Key exclusion criteria - Preoperative cognitive impairment (Level III or higher) or psychiatric symptoms hindering communication.
Preoperative motor dysfunction (unable to walk).
Preoperative LVEF < 40% or NYHA Class IV or higher.
Postoperative onset of cerebrovascular disorders (consciousness disorder or paralysis).
Inability to wean from mechanical circulatory support postoperatively.
Readmission to the ICU or death before discharge.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 03 Month 03 Day
Date of IRB - 2025 Year 03 Month 03 Day
Anticipated trial start date - 2025 Year 06 Month 01 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069503
Disclaimer: Curated by HT Syndication.