The Effect of Preoperative Active Warming on Intraoperative Body Temperature
Primary Purpose
Total Knee Arthroplasty, Intraoperative Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Prewarming
Sponsored by
About this trial
This is an interventional prevention trial for Total Knee Arthroplasty focused on measuring Surgical nursing, Inadvertent hypothermia, Perioperative period, Active warming, Comfort
Eligibility Criteria
Inclusion Criteria:
- 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<29.9 kg/m2
Exclusion Criteria:
- 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
Sites / Locations
- Hatice Özsoy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Intervention group
Control group
Arm Description
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.
The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery.
Outcomes
Primary Outcome Measures
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®.
Secondary Outcome Measures
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.
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.
Hemodynamic parameters (Blood pressure)
During the surgery, the blood pressure of the patients will be monitored every 15 minutes.
Hemodynamic parameters (pulse)
During the surgery, the patients' heart rate will be monitored every 15 minutes.
Hemodynamic parameters (oxygen saturation)
During the surgery, the oxygen saturation of the patients will be monitored every 15 minutes.
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.
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.
Full Information
NCT ID
NCT05334589
First Posted
March 26, 2022
Last Updated
January 21, 2023
Sponsor
Burdur Mehmet Akif Ersoy University
1. Study Identification
Unique Protocol Identification Number
NCT05334589
Brief Title
The Effect of Preoperative Active Warming on Intraoperative Body Temperature
Official Title
The Effect of Active Warming Before Total Knee Arthroplasty on Intraoperative Body Temperature and Comfort: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burdur Mehmet Akif Ersoy University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Intraoperative Hypothermia
Keywords
Surgical nursing, Inadvertent hypothermia, Perioperative period, Active warming, Comfort
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were divided into intervention and control groups using the block randomization method.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery.
Intervention Type
Device
Intervention Name(s)
Prewarming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative body temperature
Description
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
Throughout the operation (min.1 hours) (max. 2 hours)
Secondary Outcome Measure Information:
Title
Temperature comfort perception (before being sent to the operating room)
Description
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 operating room (min.15 minutes) (max.45 minutes)
Title
Postoperative body temperature
Description
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
Until admission to the Postanaesthesia Care Unit and sent to the clinic (min.15 minutes) (max.30 minutes)
Title
Hemodynamic parameters (Blood pressure)
Description
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)
Title
Hemodynamic parameters (pulse)
Description
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)
Title
Hemodynamic parameters (oxygen saturation)
Description
During the surgery, the oxygen saturation 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)
Title
Temperature comfort perception (before sending to the clinic)
Description
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)
Title
Patient Comfort
Description
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.
Time Frame
Before being sent to the clinic (min.15 minutes) (max.30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Özsoy, PhD Student
Organizational Affiliation
Burdur Mehmet Akif Ersoy University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatice Özsoy
City
Merkez
State/Province
Burdur
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27555196
Citation
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.
Results Reference
background
PubMed Identifier
28938977
Citation
Rosenkilde 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.
Results Reference
background
PubMed Identifier
27687449
Citation
Torossian 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.
Results Reference
background
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The Effect of Preoperative Active Warming on Intraoperative Body Temperature
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