Knee ProsthesisNCT06454877
Effect of Normothermia Care Bundle in Knee Replacement Surgery
A study testing active heating and pasive heating in people with Knee Prosthesis, run by Istanbul Saglik Bilimleri University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Prosthesis
- What is being tested?
- active heating and pasive heating
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older Planned elective knee arthroplasty surgery Patients planned for neuraxial block anesthesia ASA (American Society of Anesthesiologists) class I-III
Who cannot join
- Alcohol and drug addiction, Patients who cannot be contacted Preoperative body temperature <36 C° or ≥37.5 C°
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Normothermia Care Bundle on Inadvertent Perioperative Hypothermia, Surgical Site Infection and Bleeding in Knee Replacement Surgery
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
- Being tested
- active heating, pasive heating
- Keywords
- Hypotermia, surgical site infection, active heating, pasive heating, nursing care bundle
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active heatingDevice
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 heatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| active heating | Experimental | It is the group to be actively heated with the heating method using hot air blowing device. Receives: Device: active heating |
| pasive heating | Experimental | Passive heating using reflective blankets is the group to be made. Receives: Behavioral: pasive heating |
| control group | No intervention | The group will receive routine hospital care without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital signs observation form
in this form body temperature value will be evaluated
Measured: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
vital signs observation form
In this form, diastolic and systolic blood pressure will be evaluated
Measured: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
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.
Measured: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
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.
Measured: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
vital signs observation form
in this form heart rate will be evaluated
Measured: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
Secondary outcomes (7)
bleeding follow-up form
Hb (hemoglobin) will be evaluated in terms of bleeding.
Measured: first 3 days after surgery
bleeding follow-up form
Hct (Hemotocrit)will be evaluated in terms of bleeding.
Measured: first 3 days after surgery
bleeding follow-up form
PT(Protrombin time) will be evaluated in terms of bleeding.
Measured: first 3 days after surgery
drain follow-up form
the amount of drainage will be evaluated for bleeding
Measured: first 3 days after surgery
observation form assessing surgical site infection
WBC (White Blood Count) will be evaluated for surgical site infection
Measured: To be evaluated on the 3rd day, 10th day and 30th day after surgery
observation form assessing surgical site infection
CRP (C Reaktif Protein)will be evaluated for surgical site infection
Measured: To be evaluated on the 3rd day, 10th day and 30th day after surgery
observation form assessing surgical site infection
will be evaluated for surgical site infection
Measured: To be evaluated on the 3rd day, 10th day and 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsen Ozturk Genc, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454877
- Sponsor's protocol ID
- IstanbulSBU-OZTURKGENC-001
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normothermia Care Bundle on Inadvertent Perioperative Hypothermia, Surgical Site Infection and Bleeding in Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT06454877
- Acronym / sponsor ID
- IstanbulSBU-OZTURKGENC-001
- Conditions
- Knee Prosthesis
- Keywords
- Hypotermia, surgical site infection, active heating, pasive heating, nursing care bundle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active heating | Experimental | Device: active heatingIt is the group to be actively heated with the heating method using hot air blowing device. |
| pasive heating | Experimental | Behavioral: pasive heatingPassive heating using reflective blankets is the group to be made. |
| control group | No intervention | –The group will receive routine hospital care without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older Planned elective knee arthroplasty surgery Patients planned for neuraxial block anesthesia ASA (American Society of Anesthesiologists) class I-III
Key exclusion criteria (1 listed)
- Alcohol and drug addiction, Patients who cannot be contacted Preoperative body temperature <36 C° or ≥37.5 C°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active heatingPreheating 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°. | Device | active heating |
| pasive heatingIn 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. | Behavioural | pasive heating |
Primary outcome
vital signs observation form
Time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
in this form body temperature value will be evaluated
vital signs observation form
Time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
In this form, diastolic and systolic blood pressure will be evaluated
vital signs observation form
Time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
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.
vital signs observation form
Time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
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.
vital signs observation form
Time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery
in this form heart rate will be evaluated
7 secondary outcomes
bleeding follow-up form
Time frame: first 3 days after surgery
bleeding follow-up form
Time frame: first 3 days after surgery
bleeding follow-up form
Time frame: first 3 days after surgery
drain follow-up form
Time frame: first 3 days after surgery
observation form assessing surgical site infection
Time frame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
observation form assessing surgical site infection
Time frame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
observation form assessing surgical site infection
Time frame: To be evaluated on the 3rd day, 10th day and 30th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing active heating and pasive heating in people with Knee Prosthesis, run by Istanbul Saglik Bilimleri University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülşen Genç (05054464381, gulsenozturkgenc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs observation form (time frame: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.