Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid

Pregnancy Clinical Trial

Official title:

Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid on Preventing Hypothermia and Shivering During Cesarean Delivery Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256786
• Other study ID #: kangnamAN
• Status: Completed
• Start date: July 12, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2019
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery. Core hypothermia may be associated with a number of adverse outcomes in patients, including shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements, decreased metabolism and prolonged recovery. Shivering can result in interference with monitoring, increased tension on wound edges, and increased oxygen consumption.

A previous study has shown several modalities to prevent hypothermia and shivering in patients undergoing cesarean delivery with spinal anesthesia. But, single modality intervention have shown marginal or no efficacy.

Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also produces a lower body sympathectomy that provokes a core to peripheral redistribution of body heat. It is difficult to treat the core to peripheral redistribution of body heat. However redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes core temperature that remains well regulated, but it markedly increases peripheral tissue heat content. As a result, prewarming reduces the core to peripheral tissue temperature gradient and the propensity for redistribution after the induction of anesthesia.

We therefore hypothesized that Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid might reduce perioperative hypothermia and shivering in women undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining maternal normothermia increases newborn temperature and Apgar scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for cesarean delivery under spinal anesthesia

• The American Society of Anesthesiologists physical status class one or two

• female between 20 and 45

Exclusion Criteria:

• Patients with heart disease

• Patients with infectious disease

• Patients with coagulopathy

• Patients with a drug allergy

• In case of switching to general anesthesia

• Patients BMI under 18.5 or over 31

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Prewarming using forced air warmer, warmed intravenous fluid
Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid in active warming group

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sacred heart hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

Butwick AJ, Lipman SS, Carvalho B. Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413-9, table of contents. — 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

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. — View Citation

Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34. — 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

Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. — View Citation

Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. — View Citation

Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. — View Citation

Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. — View Citation

Rajek A, Greif R, Sessler DI. Effects of epidural anesthesia on thermal sensation. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):527-31. — View Citation

Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. — View Citation

Watkinson M. Temperature control of premature infants in the delivery room. Clin Perinatol. 2006 Mar;33(1):43-53, vi. Review. — 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: 10.10 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hypothermia and shivering		immediately after arrival at the postanesthesia care unit
Secondary	temperature of newborn		immediately after delivery of newborn