Hatice Özsoy
Merkez, Burdur, Turkey (Türkiye)
NCT Number: NCT05334589
A randomized controlled study was conducted to examine the effect of active warming before total knee arthroplasty on intraoperative body temperature and comfort.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Merkez, Burdur, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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®.
Time frame: Before being sent to the operating room (min.15 minutes) (max.45 minutes)
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.
Time frame: Until admission to the Postanaesthesia Care Unit and sent to the clinic (min.15 minutes) (max.30 minutes)
Body temperatures will be measured at 15-minute intervals until patients arrive at the Postanesthesia Care Unit and are sent to the clinic.
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
During the surgery, the blood pressure of the patients will be monitored every 15 minutes.
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
During the surgery, the patients' heart rate will be monitored every 15 minutes.
Time frame: From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)
During the surgery, the oxygen saturation of the patients will be monitored every 15 minutes.
Time frame: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
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.
Time frame: Before being sent to the clinic (min.15 minutes) (max.30 minutes)
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.
Burdur Mehmet Akif Ersoy University
Other
The Effect of Active Warming Before Total Knee Arthroplasty on Intraoperative Body Temperature and Comfort: A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07705971
Arthritis, Joint Diseases
Denizli, Turkey (Türkiye)
View Trial DetailsNCT04748549
Total Knee Arthroplasty
Boston, Massachusetts, United States
View Trial DetailsNCT06988033
Bone Diseases, Bone Diseases, Metabolic
Istanbul, Uskudar, Turkey (Türkiye)
View Trial DetailsNCT05107414
Total Knee Arthroplasty
Knoxville, Tennessee, United States
View Trial Details