The Effect of Forced Air Warming During Caseraen Section on Maternal Hypothermia: Randomized Controlled Trial

Cesarean Section Complications Clinical Trial

Official title:

The Effect Of Forced Air Warming Used For Different Body Parts During Caseraen Section On Maternal Hypothermia, Shivering, Thermal Comfort, Apgar Score And Breastfeeding: Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04667000
• Other study ID #: KA-180051
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During the cesarean section; Hypothermia can be seen due to reasons such as anesthesia, premedication drugs, cold operating room environment, exposure of tissues and organs, and use of cold intravenous fluids. Hypothermia associated with cesarean may affect maternal and fetal health negatively. As a result of hypothermia, coagulopathy, infection, undesirable cardiac events that cause an increase in oxygen consumption, delay in postoperative recovery and wound healing, postoperative nausea and vomiting, chills and relief may be observed in the mother. Newborns born from hypothermic mothers have lower body temperature, pH and Apgar scores. It is important to evaluate all women in terms of risk factors in the preoperative period in the prevention of hypothermia and complications related to hypothermia. Prevention of hypothermia, which has negative effects on maternal and newborn health, is one of the risks that the nurse can address independently. Therefore, this research; In order to determine the effect of heating different body areas using compressed air heating technique during cesarean section on hypothermia, tremor, thermal comfort, postpartum comfort and maternal satisfaction, a parallel group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Adult Hospital Gynecology and Obstetrics Department delivery room and obstetrics service. Research data, Introductory Information Form (Appendix 1), Obstetric and Postpartum Features Form (Appendix 2), Patient Monitoring Form (Appendix 3), Termal Comfort Perception Scale (Appendix 4), Shivering Level Diagnostic Form (Appendix 5), LATCH Breastfeeding The Diagnostic and Measurement Tool (Appendix 6) will be collected using the Visual Analogue Scale (Appendix 7) and the Thermal Comfort Scale that will be developed by the researchers. Pregnant women who meet the inclusion criteria will be included in the research. Women will be divided into 4 groups as the lower extremities are heated, the upper extremities are heated, the whole body is heated, and the control group. According to the group of women; It will be heated 30 minutes before surgery and 30 minutes after surgery with lower limb, upper limb or whole body. Women in the control group will not be heated.

Description:

This study was planned as a parallel group randomized controlled study in order to determine the effect of heating different body parts using forced air warming technique during cesarean section on maternal hypothermia, shivering, thermal comfort, the Apgar score of the newborn and breastfeeding. In the preparation phase of the research; Determining the rate of hypothermia in women applying to the delivery room of Hacettepe University Adult Hospital for planned cesarean section, determining and procuring the devices to be used in the study, and establishing experimental and control groups will be realized. Body temperatures of women will be measured for 2 weeks in order to determine the rate of hypothermia in women who have had cesarean section in the institution where the study will be conducted. Body temperature of women will be started 30 minutes before the cesarean section and will be measured every 15 minutes until 30 minutes after the operation. By determining the prevalence of hypothermia after cesarean section in women; It is aimed to reveal the necessity of heating with compressed air heating technique. - Women are admitted to the delivery room 60-90 minutes before the cesarean operation. The Introductory Information Form will be applied by the researcher using face-to-face interview before the women are admitted to the operating room. - 30 minutes before the operation, women's body temperature, shivering, blood pressure, pulse and respiratory values will be evaluated every 15 minutes and recorded on the Patient Monitoring Form. In addition, the Temperature Comfort Scale, which will be developed by the researchers, will be applied by face to face interview method. Applications During Cesarean Surgery - During the operation, women's body temperature, temperature comfort score, shivering, blood pressure, pulse, respiration and SpO2 values will be evaluated every 15 minutes and recorded on the Patient Monitoring Form. - With the birth of the baby; The newborn's body temperature, 1st and 5th minute Apgar score will be evaluated and recorded on the Obstetric and Postpartum Characteristics Form. Applications to be Made Within 30 Minutes After Cesarean Surgery - After the cesarean operation, women will be monitored in the recovery unit for 30 minutes. Body temperature, temperature comfort score, shivering, blood pressure, pulse, respiration and SpO2 values will be evaluated every 15 minutes after the women are admitted to the recovery unit and recorded on the Patient Monitoring Form. In addition, the Temperature Comfort Scale, which will be developed by the researchers, will be applied to women 30 minutes after the operation for the second time. - The pain level of women will be evaluated with the Visual Pain Scale 30 minutes after surgery. - In the institution where the research will be conducted, all women are given a heated blanket at 70 0C when they feel cold and shiver after cesarean section. The number of covers used varies depending on the demand of the woman. Researcher women will not interrupt this routine care they receive. The number of heated covers used by women will be recorded on the Obstetric and Postpartum Characteristics Form. Applications to be Performed in Obstetrics and Gynecology Service after Cesarean Operation - Information such as the need for analgesia, time to start breastfeeding, first mobilization time, gas, stool and urine output will be obtained from the patient file and recorded in the Obstetric and Postpartum Characteristics Form. - The pain level of women will be evaluated repeatedly with the Visual Pain Scale (VAS) at the 24th hour after surgery. Due to the effect of anesthesia and the administration of analgesics upon the request of the doctor within the first day after cesarean operation, the VAS score after 24 hours will be evaluated. - Before discharge, the development of postpartum complications in a woman will be evaluated and recorded on the Obstetric and Postpartum Features Form. - At Hacettepe University Adult Hospital Gynecology Service, the breastfeeding status of mothers of newborns is evaluated using the LATCH Breastfeeding Diagnostic and Measurement Tool. Effective breastfeeding score assessed by the nurses: LACTH score will be evaluated and recorded on the Obstetric and Postpartum Characteristics Form.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• - between the ages of 18-35
• Speak, understand and write Turkish
• 37 weeks and more pregnant
• ASA I (Normal, a disease other than surgical pathology that does not cause a systemic disorder or a healthy person without a systemic problem)
• Spinal anesthesia is planned
• No high-risk pregnancy diagnosis (Oligodydroamniosis, early membrane rupture, gestational diabetes mellitus, preeclampsia, fetal tachycardia, nonreactive NST, intrauterine growth retardation)
• Body mass index> 19 kg / m2 and <40 kg / m2,
• Having a single pregnancy and
• Pregnant women who agreed to participate in the study will be included in the sample.

Exclusion Criteria:

• - Emergency cesarean section
• Individuals with Forced Air Warming contraindications (Acute infection, Maternal fever before operation, etc.)
• In case of any complication that may develop in the mother or newborn at any stage of the research
• Pregnant women who want to leave the research at any stage of the research will be excluded from the sample.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypothermia

Intervention

Other:
• Forced Air Warming
We will use Forced Air Warming for cesarean patient

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Hacettepe University	Cigdem Yucel, Ozgur Ozyuncu

Country where clinical trial is conducted

Turkey, 

References & Publications (46)

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. — View Citation

Apfelbaum JL, Silverstein JH, Chung FF, Connis RT, Fillmore RB, Hunt SE, Nickinovich DG, Schreiner MS, Silverstein JH, Apfelbaum JL, Barlow JC, Chung FF, Connis RT, Fillmore RB, Hunt SE, Joas TA, Nickinovich DG, Schreiner MS; American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2013 Feb;118(2):291-307. doi: 10.1097/ALN.0b013e31827773e9. — View Citation

Arkiliç CF, Akça O, Taguchi A, Sessler DI, Kurz A. Temperature monitoring and management during neuraxial anesthesia: an observational study. Anesth Analg. 2000 Sep;91(3):662-6. — View Citation

Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16. — View Citation

Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005. — View Citation

Betrán AP, Ye J, Moller AB, Zhang J, Gülmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. — View Citation

Carpenter L, Baysinger CL. Maintaining perioperative normothermia in the patient undergoing cesarean delivery. Obstet Gynecol Surv. 2012 Jul;67(7):436-46. doi: 10.1097/OGX.0b013e3182605ccd. Review. — View Citation

Chakladar A, Dixon MJ, Crook D, Harper CM. The effects of a resistive warming mattress during caesarean section: a randomised, controlled trial. Int J Obstet Anesth. 2014 Nov;23(4):309-16. doi: 10.1016/j.ijoa.2014.06.003. Epub 2014 Jun 13. — View Citation

Chebbout R, Newton RS, Walters M, Wrench IJ, Woolnough M. Does the addition of active body warming to in-line intravenous fluid warming prevent maternal hypothermia during elective caesarean section? A randomised controlled trial. Int J Obstet Anesth. 2017 May;31:37-44. doi: 10.1016/j.ijoa.2017.04.008. Epub 2017 Apr 27. — View Citation

Chung SH, Lee BS, Yang HJ, Kweon KS, Kim HH, Song J, Shin DW. Effect of preoperative warming during cesarean section under spinal anesthesia. Korean J Anesthesiol. 2012 May;62(5):454-60. doi: 10.4097/kjae.2012.62.5.454. Epub 2012 May 24. — View Citation

Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181. — View Citation

Duff J, Di Staso R, Cobbe KA, Draper N, Tan S, Halliday E, Middleton S, Lam L, Walker K. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial. BMC Surg. 2012 Jul 20;12:14. doi: 10.1186/1471-2482-12-14. — View Citation

Fallis WM, Hamelin K, Symonds J, Wang X. Maternal and newborn outcomes related to maternal warming during cesarean delivery. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):324-31. — View Citation

Geller EJ, Wu JM, Jannelli ML, Nguyen TV, Visco AG. Maternal outcomes associated with planned vaginal versus planned primary cesarean delivery. Am J Perinatol. 2010 Oct;27(9):675-83. doi: 10.1055/s-0030-1249765. Epub 2010 Mar 16. — View Citation

Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7:CD007892. doi: 10.1002/14651858.CD007892.pub6. Review. Update in: Cochrane Database Syst Rev. 2020 Apr 26;4:CD007892. — View Citation

Harper CM, Andrzejowski JC, Alexander R. NICE and warm. Br J Anaesth. 2008 Sep;101(3):293-5. doi: 10.1093/bja/aen233. — View Citation

Hess PE, Snowman CE, Wang J. Hypothermia after cesarean delivery and its reversal with lorazepam. Int J Obstet Anesth. 2005 Oct;14(4):279-83. — View Citation

Horn EP, Bein B, Steinfath M, Ramaker K, Buchloh B, Höcker J. The incidence and prevention of hypothermia in newborn bonding after cesarean delivery: a randomized controlled trial. Anesth Analg. 2014 May;118(5):997-1002. doi: 10.1213/ANE.0000000000000160. — View Citation

Horn EP, Schroeder F, Gottschalk A, Sessler DI, Hiltmeyer N, Standl T, Schulte am Esch J. Active warming during cesarean delivery. Anesth Analg. 2002 Feb;94(2):409-14, table of contents. — View Citation

Jaiyeoba O. Postoperative infections in obstetrics and gynecology. Clin Obstet Gynecol. 2012 Dec;55(4):904-13. doi: 10.1097/GRF.0b013e3182714734. Review. — View Citation

Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. — View Citation

John M, Ford J, Harper M. Peri-operative warming devices: performance and clinical application. Anaesthesia. 2014 Jun;69(6):623-38. doi: 10.1111/anae.12626. Epub 2014 Apr 10. Review. — View Citation

Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. Review. — View Citation

Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. Review. — View Citation

Leeth D, Mamaril M, Oman KS, Krumbach B. Normothermia and patient comfort: a comparative study in an outpatient surgery setting. J Perianesth Nurs. 2010 Jun;25(3):146-51. doi: 10.1016/j.jopan.2010.03.010. — View Citation

Letko MD. Understanding the Apgar score. J Obstet Gynecol Neonatal Nurs. 1996 May;25(4):299-303. — View Citation

May T, Seder DB, Fraser GL, Tu C, McCrum B, Lucas L, Riker RR. Association of the Bedside Shivering Assessment Scale and derived EMG power during therapeutic hypothermia in survivors of cardiac arrest. Resuscitation. 2011 Aug;82(8):1100-3. doi: 10.1016/j.resuscitation.2011.03.037. Epub 2011 Apr 16. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum in: J Clin Epidemiol. 2012 Mar;65(3):351. — View Citation

Mpogoro FJ, Mshana SE, Mirambo MM, Kidenya BR, Gumodoka B, Imirzalioglu C. Incidence and predictors of surgical site infections following caesarean sections at Bugando Medical Centre, Mwanza, Tanzania. Antimicrob Resist Infect Control. 2014 Aug 11;3:25. doi: 10.1186/2047-2994-3-25. eCollection 2014. — View Citation

Mylonas I, Friese K. Indications for and Risks of Elective Cesarean Section. Dtsch Arztebl Int. 2015 Jul 20;112(29-30):489-95. doi: 10.3238/arztebl.2015.0489. Review. — View Citation

Ng SF, Oo CS, Loh KH, Lim PY, Chan YH, Ong BC. A comparative study of three warming interventions to determine the most effective in maintaining perioperative normothermia. Anesth Analg. 2003 Jan;96(1):171-6, table of contents. — View Citation

Paris LG, Seitz M, McElroy KG, Regan M. A randomized controlled trial to improve outcomes utilizing various warming techniques during cesarean birth. J Obstet Gynecol Neonatal Nurs. 2014 Nov-Dec;43(6):719-28. doi: 10.1111/1552-6909.12510. Epub 2014 Oct 14. — View Citation

Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4. — View Citation

Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. Review. — View Citation

Sahin A, Aypar U. Effect of amino acid solutions on intraoperative hypothermia and postoperative shivering. Comparison of two anesthetic regimens. Acta Anaesthesiol Scand. 2002 Jan;46(1):64-7. — View Citation

Scott EM, Buckland R. A systematic review of intraoperative warming to prevent postoperative complications. AORN J. 2006 May;83(5):1090-104, 1107-13. Review. — View Citation

Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. Review. — View Citation

Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. Review. — View Citation

Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;(10):CD007482. doi: 10.1002/14651858.CD007482.pub3. Review. — View Citation

Sultan P, Habib AS, Cho Y, Carvalho B. The Effect of patient warming during Caesarean delivery on maternal and neonatal outcomes: a meta-analysis. Br J Anaesth. 2015 Oct;115(4):500-10. doi: 10.1093/bja/aev325. Review. — View Citation

Torloni MR, Betran AP, Souza JP, Widmer M, Allen T, Gulmezoglu M, Merialdi M. Classifications for cesarean section: a systematic review. PLoS One. 2011 Jan 20;6(1):e14566. doi: 10.1371/journal.pone.0014566. Review. — View Citation

Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. — View Citation

Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;(11):CD009892. doi: 10.1002/14651858.CD009892.pub2. Review. — View Citation

Woolnough M, Allam J, Hemingway C, Cox M, Yentis SM. Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial. Int J Obstet Anesth. 2009 Oct;18(4):346-51. doi: 10.1016/j.ijoa.2009.02.009. Epub 2009 Aug 7. — View Citation

Wu X. The safe and efficient use of forced-air warming systems. AORN J. 2013 Mar;97(3):302-8. doi: 10.1016/j.aorn.2012.12.008. — View Citation

Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6. — View Citation

* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Hypothermia	Maternal hypothermia is defined as body temperature falling below 36 ° C.	30 minutes before the intervention to 30 minutes after the intervention.
Secondary	Shivering	Shivering is a bodily function in response to cold in humans	30 minutes before the intervention to 30 minutes after the intervention.
Secondary	Thermal Comfort	Thermal comfort is defined as the condition of mind that expresses satisfaction with the thermal environment.	30 minutes before the intervention to 30 minutes after the intervention.
Secondary	Apgar Score	An objective score of the condition of a baby after birth. This score is determined by scoring the heart rate, respiratory effort, muscle tone, skin color, and response to a catheter in the nostril.	30 minutes before the intervention to 30 minutes after the intervention.
Secondary	Breastfeeding Timing	The time between the start of breastfeeding of the newborn after birth	30 minutes before the intervention to 30 minutes after the intervention.