Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06454877
Other study ID # IstanbulSBU-OZTURKGENC-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information

Verified date June 2024
Source Istanbul Saglik Bilimleri University
Contact Gülsen Genç
Phone 05054464381
Email gulsenozturkgenc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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°

Study Design


Related Conditions & MeSH terms


Intervention

Device:
active heating
Preheating will be performed for 15 minutes 30 minutes before surgery with a hot air blowing device in accordance with the normothermia care package so that the body temperature is 36-37 C°. Active heating during surgery will be done with a heating bed placed on the operating table. Patients taken to the postoperative care unit will continue to be heated with a hot air blower and the device will be turned off when the body temperature reaches 37 C°.
Behavioral:
pasive heating
In accordance with the normothermia care package, the reflective blanket will be covered to cover the whole body 30 minutes before surgery. During the operation, the body will be covered with a reflective blanket in accordance with the surgical intervention. Patients taken to the postoperative care unit will continue to be warmed with reflective blankets.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Saglik Bilimleri University

Outcome

Type Measure Description Time frame Safety issue
Primary vital signs observation form in this form body temperature value will be evaluated Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Primary vital signs observation form In this form, diastolic and systolic blood pressure will be evaluated Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Primary vital signs observation form in this form thermal comfort score will be evaluated. Thermal comfort scale evaluation will be evaluated with a visual analog scale. It is a scale with 10 points at one end of the scale and 100 points at the other end. The patient will be asked to mark his/her comfort level. Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Primary vital signs observation form in this form level of tremor will be evaluated.The tremor level evaluation form is evaluated between 0-3. 0 points: no tremor, 1 Mild: tremor localized only in the neck and/or thorax, 2 Moderate: tremor in the neck, thorax and upper extremities, 3 Severe: It is evaluated as tremors in the trunk, upper and lower extremities. Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Primary vital signs observation form in this form heart rate will be evaluated Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Secondary bleeding follow-up form Hb (hemoglobin) will be evaluated in terms of bleeding. first 3 days after surgery
Secondary bleeding follow-up form Hct (Hemotocrit)will be evaluated in terms of bleeding. first 3 days after surgery
Secondary bleeding follow-up form PT(Protrombin time) will be evaluated in terms of bleeding. first 3 days after surgery
Secondary drain follow-up form the amount of drainage will be evaluated for bleeding first 3 days after surgery
Secondary observation form assessing surgical site infection WBC (White Blood Count) will be evaluated for surgical site infection To be evaluated on the 3rd day, 10th day and 30th day after surgery
Secondary observation form assessing surgical site infection CRP (C Reaktif Protein)will be evaluated for surgical site infection To be evaluated on the 3rd day, 10th day and 30th day after surgery
Secondary observation form assessing surgical site infection will be evaluated for surgical site infection To be evaluated on the 3rd day, 10th day and 30th day after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT06134999 - Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation N/A
Recruiting NCT06346717 - Mobile Application Based Care for Total Knee Prosthesis Patients N/A
Not yet recruiting NCT05387694 - Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery. N/A
Completed NCT01864434 - In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
Completed NCT05233423 - Pressurized Cold Application for Patients Total Knee Prosthesis Surgery N/A
Recruiting NCT06367842 - Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)
Completed NCT03634124 - Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs Phase 3
Completed NCT01290627 - In Vivo Determination of 3D Patellofemoral Mechanics
Completed NCT01290640 - Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Completed NCT02319915 - Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation. Early Phase 1
Recruiting NCT06422585 - Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
Completed NCT02018484 - Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides. N/A
Completed NCT01714492 - Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA