An interventional study of Forced Air Warming and Peripheral Carbon Fiber Warming in Inadvertent Perioperative Hypothermia, sponsored by Bozok University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Bozok University · Not applicable, Interventional, and Supportive care
Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.
The parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are performed in clinics. All patients are male and female patients who have undergone surgery and met the inclusion criteria.
498 studies on the registry are indexed under Hypothermia; 53 are open to participants now.
This study's enrollment of 123 is above the median of 80 across 350 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Bozok University is the lead sponsor of 53 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
There is no intervention in patients before the operation. When he comes out of the operation and comes to the post-anesthesia care unit (PACU), he is warmed by forced air. When the body temperature of the patients reaches 36 ° C, they are transferred to the clinic with a cover and blanket.
Device: Forced Air Warming
Gloves and socks developed by the researcher are applied half an hour before the operation. These materials, called environmental warming, have three layers. The first layer in contact with the patient is a thermal inner sheath made of 90% Polyester and 10% Polyamide and is used to maintain body temperature. The second layer consists of carbon fiber warmer and foil. The end of the carbon fiber warmer is USB connected. When the connection is plugged in, the warmer works. The third layer is again made of thermal fabric. A rubber bandage is made to separate the last layer from the external environment and to maintain the patient's body temperature. The USB connection is removed while patients are sent for surgery. After the operation, rewarming is started in the post-anesthesia care unit. When the patient's body temperature reaches 36 ° C, he is transferred to the clinic with a cover and blanket.
Device: Peripheral Carbon Fiber Warming
A routine hospital procedure is applied. The patient is not warmed before going to surgery. A cover and blanket are used passively after being taken to the PACU from the operation.
It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.
It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.
Pain Visual Analog Scale
The Visual Pain Scale is a scale of ten centimeters, created to inquire about the pain status of individuals. Zero indicates no pain while ten indicates the most severe pain. This chart is prepared as a blank line for self-evaluation and the prepared chart is read on the ruler.
Time frame: It is measured preoperatively and after the end of the operation at the 30th minute, 12th hour and 24th hour (up to 24 hours). Change from baseline Pain Visual Analog Scale scores at 24 hours.
Thermal Comfort Visual Analog Scale
Horn et al. It is a visual assessment scale developed by. Thermal comfort is evaluated using a 100 mm long visual benchmark scale. Zero points represent the worst unbearable cold, 50 mm thermal comfort, 100 mm unbearable temperature. Objective responses of the patients were determined by making an evaluation from 0 to 100mm.
Time frame: It is measured before surgery and every half hour after surgery (up to 2 hours). The change in thermal comfort score before and within the first two hours after surgery is recorded.
Body Temperature Scale
It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.
Time frame: It is measured before surgery and every fifteen minutes after surgery (up to 2 hours). The change in Body Temperature Scale score before and within the first two hours after surgery is recorded.
Tremor Rating Scale
Badjatia et al. it is a visual assessment scale developed by. The tremor intensity rating scale is a visual evaluation scale that is observed and evaluated by researchers. When the quality of the tremor is evaluated numerically; 0: no flickering; 1: tremor localized in the abdomen and neck; 2: tremors, including upper limbs; and 3: whole body tremors.
Time frame: It is measured before and every 15 minutes after surgery (up to 1 hour). Changes in tremor from the first minute to an hour after surgery.
Hemoglobin Parameters Scale
Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.
Time frame: The hemoglobin level is measured before surgery and at 24th hours after surgery (up to 24 hours). Change from baseline hemoglobin level scores at 24 hours.
International Normalized Ratio Parameters Scale
International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.
Time frame: The Pt INR level is measured before surgery and at 1th hours after surgery (up to 1 hours). Change from preoperative Pt INR level at postoperative 1st hour.
Plan to share: No
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