Clinical trial NCT06454877: Effect of Normothermia Care Bundle in Knee Replacement Surgery
Official title: Effect of Normothermia Care Bundle on Inadvertent Perioperative Hypothermia, Surgical Site Infection and Bleeding in Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Prosthesis
Keywords: Hypotermia
surgical site infection
active heating
pasive heating
nursing care bundle
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 individual's 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 22.0 program.


Eligibility criteria: Inclusion Criteria:

18 years or older Planned elective knee arthroplasty surgery Patients planned for neuraxial block anesthesia ASA (American Society of Anesthesiologists) class I-III

Exclusion Criteria:

Alcohol and drug addiction, Patients who cannot be contacted Preoperative body temperature \<36 C° or ≥37.5 C°

Primary outcomes:
measure: vital signs observation form
timeFrame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
measure: vital signs observation form
timeFrame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
measure: vital signs observation form
timeFrame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
measure: vital signs observation form
timeFrame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
measure: vital signs observation form
timeFrame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Secondary outcomes:
measure: bleeding follow-up form
timeFrame: first 3 days after surgery
measure: bleeding follow-up form
timeFrame: first 3 days after surgery
measure: bleeding follow-up form
timeFrame: first 3 days after surgery
measure: drain follow-up form
timeFrame: first 3 days after surgery
measure: observation form assessing surgical site infection
timeFrame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
measure: observation form assessing surgical site infection
timeFrame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
measure: observation form assessing surgical site infection
timeFrame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
Other outcomes:
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