Total Knee ArthroplastyNCT05334589
The Effect of Preoperative Active Warming on Intraoperative Body Temperature
A study testing Prewarming in people with Total Knee Arthroplasty and Intraoperative Hypothermia, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled study was conducted to examine the effect of active warming before total knee arthroplasty on intraoperative body temperature and comfort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Intraoperative Hypothermia
- What is being tested?
- Prewarming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2021to 29 Jul 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who volunteered to participate in the study
- Elective surgery planned
- Patients between the ages of 18-80
- ASA I-III
- Neuroaxial anesthesia applied
- No sensory problems (hearing, vision)
- No psychiatric illness
- 18.5<BMI<39.9 kg/m2
Who cannot join
- Body temperature <36°C at the entrance to the operating room
- Preoperative body temperature <36°C
- Patients who develop complications during preheating (blood pressure rise, patients are uncomfortable with the heat, they are agitated)
- Peripheral vascular disease
- Patients with communication difficulties
- Patients with infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Active Warming Before Total Knee Arthroplasty on Intraoperative Body Temperature and Comfort: A Randomized Control Trial
A randomized controlled study was conducted to examine the effect of active warming before total knee arthroplasty on intraoperative body temperature and comfort.
Read the detailed description
Inadvertent perioperative hypothermia is defined as a patient's internal temperature below 36 °C in surgical settings. All patients undergoing surgery and other invasive procedures are at risk of developing undesirable hypothermia. Both general and neuraxial anesthesia greatly impair thermoregulatory control, and as a result, unwarmed surgical patients become hypothermic. General and regional anesthesia causes undesirable hypothermia as a result of the redistribution of body temperature from the center to the periphery.
In the perioperative period, patients over 60 years of age with poor nutritional status, low core temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, premedication, type of surgery, dry and cold anesthetic gases, cold intravenous fluids, flushes, blood products (cold fluids direct core temperature) Hypothermia is caused by low ambient temperature, wet skin, dressings or sheets, anesthetic agents, large open cavity or abdominal surgery, excessive blood loss, drugs used before surgery.
There are many methods to maintain the body temperature of patients (passive isolation methods) or to warm the patient (active warming methods). Passive insulation methods include heated cotton blankets, surgical drapes, and thermal suits. Active heating techniques include compressed air heaters, electric heating blankets, and heated liquids and gases.
In the literature, studies on active and passive heating methods have been found in order to prevent undesirable hypothermia. There are studies with stand-alone active heating methods (such as pressurized hot air blowing systems, heated liquids, circulating hot water systems) and combined methods. Because the results of these studies were different, a randomized controlled study was planned to investigate the effectiveness of the prewarming intervention, to support the surgical process nurses in clinical practice, and to increase the reliability of the results, before developing a procedure related to prewarming.
In the study, the effect of prewarming with a hot air blowing system before the surgical procedure on the patients who will undergo total knee arthroplasty, on the patient's body temperature during the operation and on the comfort in the early postoperative period will be determined.
- Being tested
- Prewarming
- Keywords
- Surgical nursing, Inadvertent hypothermia, Perioperative period, Active warming, Comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrewarmingDevice
When patients in the study group come to the Preoperative Care Unit (PCU), their body temperature will be measured. Patients in the study group will be placed in such a way that the 3M™ Bair Hugger™ Whole Body Blanket covers the patient's body and prewarmed with the 3M™ Bair Hugger™ Warming Unit for 30 minutes before anesthesia is given in the PCU. Heating unit temperature will be adjusted to 43°C in line with company recommendations. After the patients in the study group are warmed up for 30 minutes, the preheating process will be completed and the whole body blanket will be taken and the blankets that the clinic routinely use for each patient will be covered to cover the patients' body.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | Patients in the intervention group will be prewarming with a hot air blowing system for 30 minutes before the operation. The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery. Receives: Device: Prewarming |
| Control group | No intervention | The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative body temperature
During the operation, the body temperature of the patients will be measured at 15-minute intervals from the beginning of the incision to the end of the operation.
Patients' body temperature will be measured tympanically using Braun ThermoScan® 7 Age Precision®.
Measured: Throughout the operation (min.1 hours) (max. 2 hours)
Secondary outcomes (7)
Temperature comfort perception (before being sent to the operating room)
Temperature Comfort Perception Scale: Verbal Numeric Rating Scale (VNRS) between 1 and 10 (0=very comfortable; 10=very uncomfortable) will be used to objectively evaluate the temperature comfort perception of the patients.
Measured: Before being sent to the operating room (min.15 minutes) (max.45 minutes)
Postoperative body temperature
Body temperatures will be measured at 15-minute intervals until patients arrive at the Postanesthesia Care Unit and are sent to the clinic.
Measured: Until admission to the Postanaesthesia Care Unit and sent to the clinic (min.15 minutes) (max.30 minutes)
Hemodynamic parameters (Blood pressure)
During the surgery, the blood pressure of the patients will be monitored every 15 minutes.
Measured: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Hemodynamic parameters (pulse)
During the surgery, the patients' heart rate will be monitored every 15 minutes.
Measured: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Hemodynamic parameters (oxygen saturation)
During the surgery, the oxygen saturation of the patients will be monitored every 15 minutes.
Measured: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Temperature comfort perception (before sending to the clinic)
Temperature Comfort Perception Scale: Verbal Numeric Rating Scale (VNRS) between 1 and 10 (0=very comfortable; 10=very uncomfortable) will be used to objectively evaluate the temperature comfort perception of the patients.
Measured: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
Patient Comfort
The comfort levels of the patients who are decided to be taken from the PACU to the clinic will be measured with the Perianesthesia Comfort Scale. The highest total score that can be obtained from the scale is 144, and the lowest total score is 24. The average value is determined by dividing the total score obtained by the number of scale items, and the result is indicated in the 1-6 distribution. Low score indicates bad comfort, high score indicates good comfort.
Measured: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start2 Nov 2021
- Primary completion8 Jun 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Model description
- Patients were divided into intervention and control groups using the block randomization method.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Özsoy, Burdur Mehmet Akif Ersoy University
- Investigators
- Hatice Özsoy, PhD Student, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334589
- Sponsor's protocol ID
- ErsoyU
- Status last verified
- Jan 2023
- First submitted
- 26 Mar 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akhtar Z, Hesler BD, Fiffick AN, Mascha EJ, Sessler DI, Kurz A, Ayad S, Saager L. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery. J Clin Anesth. 2016 Sep;33:376-85. doi: 10.1016/j.jclinane.2016.04.041. Epub 2016 Jun 3.
PubMed 27555196Rosenkilde C, Vamosi M, Lauridsen JT, Hasfeldt D. Efficacy of Prewarming With a Self-Warming Blanket for the Prevention of Unintended Perioperative Hypothermia in Patients Undergoing Hip or Knee Arthroplasty. J Perianesth Nurs. 2017 Oct;32(5):419-428. doi: 10.1016/j.jopan.2016.02.007. Epub 2016 Dec 9.
PubMed 28938977Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.
PubMed 27687449
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Warming Before Total Knee Arthroplasty on Intraoperative Body Temperature and Comfort: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05334589
- Acronym / sponsor ID
- ErsoyU
- Keywords
- Surgical nursing, Inadvertent hypothermia, Perioperative period, Active warming, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 19 Apr 2022 (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.
A randomized controlled study was conducted to examine the effect of active warming before total knee arthroplasty on intraoperative body temperature and comfort.
Detailed description
Inadvertent perioperative hypothermia is defined as a patient's internal temperature below 36 °C in surgical settings. All patients undergoing surgery and other invasive procedures are at risk of developing undesirable hypothermia. Both general and neuraxial anesthesia greatly impair thermoregulatory control, and as a result, unwarmed surgical patients become hypothermic. General and regional anesthesia causes undesirable hypothermia as a result of the redistribution of body temperature from the center to the periphery.
In the perioperative period, patients over 60 years of age with poor nutritional status, low core temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, premedication, type of surgery, dry and cold anesthetic gases, cold intravenous fluids, flushes, blood products (cold fluids direct core temperature) Hypothermia is caused by low ambient temperature, wet skin, dressings or sheets, anesthetic agents, large open cavity or abdominal surgery, excessive blood loss, drugs used before surgery.
There are many methods to maintain the body temperature of patients (passive isolation methods) or to warm the patient (active warming methods). Passive insulation methods include heated cotton blankets, surgical drapes, and thermal suits. Active heating techniques include compressed air heaters, electric heating blankets, and heated liquids and gases.
In the literature, studies on active and passive heating methods have been found in order to prevent undesirable hypothermia. There are studies with stand-alone active heating methods (such as pressurized hot air blowing systems, heated liquids, circulating hot water systems) and combined methods. Because the results of these studies were different, a randomized controlled study was planned to investigate the effectiveness of the prewarming intervention, to support the surgical process nurses in clinical practice, and to increase the reliability of the results, before developing a procedure related to prewarming.
In the study, the effect of prewarming with a hot air blowing system before the surgical procedure on the patients who will undergo total knee arthroplasty, on the patient's body temperature during the operation and on the comfort in the early postoperative period will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were divided into intervention and control groups using the block randomization method.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Device: PrewarmingPatients in the intervention group will be prewarming with a hot air blowing system for 30 minutes before the operation. The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery. |
| Control group | No intervention | –The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who volunteered to participate in the study
- Elective surgery planned
- Patients between the ages of 18-80
- ASA I-III
- Neuroaxial anesthesia applied
Key exclusion criteria (6 listed)
- Body temperature <36°C at the entrance to the operating room
- Preoperative body temperature <36°C
- Patients who develop complications during preheating (blood pressure rise, patients are uncomfortable with the heat, they are agitated)
- Peripheral vascular disease
- Patients with communication difficulties
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 |
|---|---|---|
| PrewarmingWhen patients in the study group come to the Preoperative Care Unit (PCU), their body temperature will be measured. Patients in the study group will be placed in such a way that the 3M™ Bair Hugger™ Whole Body Blanket covers the patient's body and prewarmed with the 3M™ Bair Hugger™ Warming Unit for 30 minutes before anesthesia is given in the PCU. Heating unit temperature will be adjusted to 43°C in line with company recommendations. After the patients in the study group are warmed up for 30 minutes, the preheating process will be completed and the whole body blanket will be taken and the blankets that the clinic routinely use for each patient will be covered to cover the patients' body. | Device | Experimental: Intervention group |
Primary outcome
Intraoperative body temperature
Time frame: Throughout the operation (min.1 hours) (max. 2 hours)
During the operation, the body temperature of the patients will be measured at 15-minute intervals from the beginning of the incision to the end of the operation. Patients' body temperature will be measured tympanically using Braun ThermoScan® 7 Age Precision®.
7 secondary outcomes
Temperature comfort perception (before being sent to the operating room)
Time frame: Before being sent to the operating room (min.15 minutes) (max.45 minutes)
Postoperative body temperature
Time frame: Until admission to the Postanaesthesia Care Unit and sent to the clinic (min.15 minutes) (max.30 minutes)
Hemodynamic parameters (Blood pressure)
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Hemodynamic parameters (pulse)
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Hemodynamic parameters (oxygen saturation)
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
Temperature comfort perception (before sending to the clinic)
Time frame: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
Patient Comfort
Time frame: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 27555196Akhtar Z, Hesler BD, Fiffick AN, Mascha EJ, Sessler DI, Kurz A, Ayad S, Saager L. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery. J Clin Anesth. 2016 Sep;33:376-85. doi: 10.1016/j.jclinane.2016.04.041. Epub 2016 Jun 3.
- Background: PubMed 28938977Rosenkilde C, Vamosi M, Lauridsen JT, Hasfeldt D. Efficacy of Prewarming With a Self-Warming Blanket for the Prevention of Unintended Perioperative Hypothermia in Patients Undergoing Hip or Knee Arthroplasty. J Perianesth Nurs. 2017 Oct;32(5):419-428. doi: 10.1016/j.jopan.2016.02.007. Epub 2016 Dec 9.
- Background: PubMed 27687449Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.
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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.
Hatice Özsoy, PhD Student principal investigator
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prewarming in people with Total Knee Arthroplasty and Intraoperative Hypothermia, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative body temperature (time frame: Throughout the operation (min.1 hours) (max. 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334589, which also lists 3 linked publications.
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 25 Jan 2023.