Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454877
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
Effect of Normothermia Care Bundle in Knee Replacement Surgery
Sponsor:
Istanbul Saglik Bilimleri University
Organization:
Istanbul Saglik Bilimleri University
Study Overview
Official Title:
Effect of Normothermia Care Bundle on Inadvertent Perioperative Hypothermia Surgical Site Infection and Bleeding in Knee Replacement Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoarthritis is a disease characterized by disruption of the integrity of articular cartilage as a result of erosion of articular cartilage Knee osteoarthritis causes muscle weakness crepitation and deformities in the knee joint limiting the individuals movement and causing loss of function The most prominent feature is pain Therefore knee replacement surgery is performed in advanced cases where pharmacologic treatment is not effective Many complications can be seen during the operation process and some of them may occur due to hypothermia Studies have reported that warming during the operation prevents hypothermia and reduces complications In this study it was aimed to examine the effect of active and passive heating applied before during and after surgery on hypothermia surgical site infections and bleeding The population of the study will consist of patients who underwent knee replacement surgery in the Orthopedics and Traumatology Clinic of Üsküdar State Hospital between April 2024 and April 2025 Data will be collected using the patient identification form normothermia care package observation form preoperative follow-up form postoperative follow-up form and postoperative long-term follow-up form A randomization list generated from a computer-based random numbers table will be used to determine which group of patients will be included in the study Patients will be followed up in 3 periods preoperative intraoperative and postoperative periods The postoperative period will be evaluated in five stages as day 1 day 2 day 3 day 10 and day 30 The purpose of the study and the intervention to be applied will be explained to all groups to be included in the study by the researcher and written and verbal consent will be obtained from the volunteers The groups included in the study will be subjected to the heating protocol according to the normothermia care package Group A will receive active heating with the heating method using a hot air blowing device Group B will receive passive heating using a reflective blanket Group C was planned as a control group to be heated by applying the routine heating procedure of the hospital without any intervention Body temperature and vital signs will be checked preoperatively and warming will be performed 30 minutes before surgery and warming will be started 15 minutes before anesthesia induction during surgery and body temperature and vital signs will be checked After the operation and in the ward warming will be performed until the body temperature reaches 37 C The data obtained will be analyzed using SPSS Statistical Package for Social Sciences for Windows 220 program
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None