Effect of Normothermia Care Bundle in Knee Replacement Surgery

NCT ID: NCT06454877

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Knee Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

active heating

It is the group to be actively heated with the heating method using hot air blowing device.

Group Type: EXPERIMENTAL

active heating

Intervention Type: DEVICE

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°.

pasive heating

Passive heating using reflective blankets is the group to be made.

Group Type: EXPERIMENTAL

pasive heating

Intervention Type: BEHAVIORAL

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.

control group

The group will receive routine hospital care without any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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°.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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°

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: lead

Responsible Party

Gulsen Ozturk Genc

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Gülşen Genç

Role: CONTACT

gulsenozturkgenc@gmail.com

05054464381

Other Identifiers

IstanbulSBU-OZTURKGENC-001

Identifier Type: -

Identifier Source: org_study_id