Impact of Active Heating on Maternal and Neonatal Well-being
NCT ID: NCT06259942
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2022-06-19
2022-09-22
Brief Summary
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Detailed Description
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The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups.
Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p\<0.05 was accepted.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention 1 group
only the group heated throughout surgery with carbon fiber underbody heaters
İntervention 1 group (underbody heater group only)
Resistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact.
Control Group
no active heating treatment was applied in this group
Intervention 2 group
the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids
İntervention 2 group (group using both underbody heater and heated iv liquid)
IV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25˚C in adults. Therefore, the fluids given to the patient should be heated to 33 40˚C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters.
Control group
routine practice of the hospital where the surgery was performed (no heater applied group)
No interventions assigned to this group
Interventions
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İntervention 1 group (underbody heater group only)
Resistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact.
İntervention 2 group (group using both underbody heater and heated iv liquid)
IV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25˚C in adults. Therefore, the fluids given to the patient should be heated to 33 40˚C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters.
Control Group
no active heating treatment was applied in this group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 37 weeks of gestation and above,
* with ASA I and ASA II scores,
* Pregnant women with a healthy fetus,
* The preoperative fasting period is between 2 to 12 hours,
* Pregnant women who were normothermic (36 to 37.5°C) preoperatively
Exclusion Criteria
* Multiple pregnancies,
* Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
* Central body temperature above 37.5°C and below 36°C on the morning of surgery
* Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
* Pregnant women with chronic bowel problems and urinary system problems were not included in the study.
19 Years
45 Years
FEMALE
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Dilek Talhaoglu
principal investigator
Principal Investigators
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Dilek TALHAOĞLU, PhD
Role: PRINCIPAL_INVESTIGATOR
She was a doctoral student at Erciyes University, Institute of Health Sciences.
Locations
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Erciyes Unıversty
Kayseri, , Turkey (Türkiye)
Countries
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Other Identifiers
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Surgery-01
Identifier Type: -
Identifier Source: org_study_id
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