Clinical Trials Logo

Clinical Trial Summary

70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery occurs later. Low body temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, exposure of large body surface areas, evaporative heat loss during skin preparation using volatile solutions, large open cavity or abdominal surgery longer operative time and exposure to anesthesia, during surgical intervention excessive blood loss etc. surgical intervention poses a risk for the formation of undesirable hypothermia. Cardiovascular and respiratory system problems that may increase mortality due to hypothermia in surgical patients; may cause a decrease in heart rhythm, cardiac output, blood pressure and oxygen saturation, and an increased risk of cardiac arrest and ischemia. With the development of shivering, oxygen consumption increases and the "thermal comfort" of the patient deteriorates. The length of stay in the postoperative unit and hospital stay are prolonged, causing an increase in costs. Among the rapid recovery protocols, it is recommended to pre-warm the patients in the preoperative period to maintain normothermia. Many complications are prevented by different methods and warming procedures performed in the perioperative period. In our study, it was aimed to compare the effects of active and passive warming on hypothermia, vital signs and warmth comfort in the postoperative period in patients who will undergo open abdominal surgery.


Clinical Trial Description

Before starting the research, permission was obtained from Çukurova University Medical Faculty Balcalı Hospital General Surgery Department Academic Committee and Operating Room Committee, from Balcalı Hospital Chief Physician (Annex-11), and Çukurova Ethics Committee by the investigator . University Faculty of Medicine Non-Interventional Research Ethics Committee approval was received with the date and number of 10.04.2020/98-29 An application was made to the Scientific Research Projects Unit to support the project with all permissions. It has been approved as a Scientific Research Project. In accordance with the results of the power analysis using the G power 3.1.9.2 program, it was planned to include 30 participants in the active warming group, 30 partici in the passive warming group and 30 participants in the control group, and a simple randomization method was used in the distribution. Sample for study groups Research data were collected in the operating room preoperative unit and postoperative unit between July 2020 and December 2020. When the participants came to the preoperative unit before the operation, his vital signs, temperature comfort perception scale and shivering level, temperature and humidity of the room were measured by the investigator and recorded in the Personal Information Form, Vital Signs Monitoring Form, Temperature Comfort Perception Scale Form, Shivering Level Diagnostic Form. Before anesthesia was given, one group was heated with the 3M Bair Hugger Model 775 Heating Unit (Hot Air Blowing Warmer Blanket) with an active heating system and the other group with a passive heating system (wool blanket) for 20 minutes, routine application was made to the control group participants by the investigator . Vital signs, tremor levels and temperature comfort perception measurements were made at the 0th, 15th, and 30th minutes in the postoperative unit of the participants after the operation by the investigator . Statistical analyzes of the collected data were made using a package program called SPSS (IBM SPSS Statistics 24). Frequency tables and descriptive statistics were used to interpret the findings. In accordance with parametric methods, the "ANOVA" test (F-table value) was used to compare the measurement values of three or more independent groups, and the "RepeatedMeasures" test (F-Table) was used to compare the measurement values of three or more dependent groups. The "Mann-Whitney U" test (Z-table value) and the "Kruskal-Wallis H" test (χ2- table value) were used to compare the measurement values of two independent groups in accordance with non-parametric methods. ) method was used. "Wilcoxon" test (Z-table value) to compare measurement values of two dependent groups, "Friedman" test (χ2-table value) to compare measurement values of three or more dependent groups, "Pearson-χ2 To examine the relationships between two qualitative variables used "cross tables" were used. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04997694
Study type Interventional
Source Cukurova University
Contact
Status Completed
Phase N/A
Start date June 23, 2021
Completion date September 18, 2021

See also
  Status Clinical Trial Phase
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Not yet recruiting NCT05306392 - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation N/A
Completed NCT02685176 - Head and Torso Rewarming Using a Human Model for Severe Hypothermia N/A
Withdrawn NCT02812069 - WarmSmart Warming Protocol N/A
Completed NCT02586974 - Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response N/A
Not yet recruiting NCT02211703 - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia N/A
Completed NCT02121574 - Accuracy of Zero-flux and Ingestible Thermometers N/A
Completed NCT02177903 - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes N/A
Completed NCT02742818 - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models N/A
Recruiting NCT01866384 - Targeted Temperature Management After Intracerebral Hemorrhage Phase 2
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01722955 - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care N/A
Completed NCT01793337 - Core Body Temperature Measurement During Hot and Cold Environmental Exposure N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Terminated NCT01018576 - Delayed Cord Clamping in Premature Infants N/A
Completed NCT00904228 - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room N/A
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Completed NCT00334360 - Dexmed/Buspirone Synergism on Shivering Phase 4
Not yet recruiting NCT06283771 - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering N/A
Completed NCT04399902 - Study to Actively Warm Trauma Patients N/A