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CompletedNCT03256786Updated Feb 27, 2019

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

An observational study in Pregnancy, sponsored by Hallym University Kangnam Sacred Heart Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Hallym University Kangnam Sacred Heart Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Pregnancy

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Keywords

  • cesarean delivery with spinal anesthesia
  • Hypothermia and shivering
  • Active warming
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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients scheduled for cesarean delivery under spinal anesthesia

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Active warming

    preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid

    Behavioral: Prewarming using forced air warmer, warmed intravenous fluid

  • Control

    no preoperative warming and room temperature intravenous fluid

Interventions

  • BehavioralPrewarming 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

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What researchers measure

Primary outcomes

  1. incidence of hypothermia and shivering

    Time frame: immediately after arrival at the postanesthesia care unit

Secondary outcomes

  1. temperature of newborn

    Time frame: immediately after delivery of newborn

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Study locations

1 site
  • Kangnam sacred heart hospital
    Seoul, Yeongdeungpo-gu KS013, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 22926250 ↗
  • 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. doi: 10.1056/NEJM199605093341901. PubMed 8606715 ↗
  • 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. PubMed 9087467 ↗
  • 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. doi: 10.1016/s0140-6736(96)90466-3. PubMed 8569362 ↗
  • 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. doi: 10.1038/sj.jp.7211289. PubMed 15861196 ↗
  • Watkinson M. Temperature control of premature infants in the delivery room. Clin Perinatol. 2006 Mar;33(1):43-53, vi. doi: 10.1016/j.clp.2005.11.018. PubMed 16533632 ↗
  • 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. doi: 10.1213/01.ane.0000286167.96410.27. PubMed 17959975 ↗
  • 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. PubMed 19502035 ↗
  • 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. PubMed 26895002 ↗
  • 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. doi: 10.1097/00000539-200202000-00034. PubMed 11812709 ↗
  • Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008. PubMed 7486181 ↗
  • 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. doi: 10.1097/00000542-199503000-00008. PubMed 7879935 ↗
  • Rajek A, Greif R, Sessler DI. Effects of epidural anesthesia on thermal sensation. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):527-31. doi: 10.1053/rapm.2001.25924. PubMed 11707791 ↗
  • 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. PubMed 22679543 ↗
  • Jun JH, Chung MH, Jun IJ, Kim Y, Kim H, Kim JH, Choi YR, Choi EM. Efficacy of forced-air warming and warmed intravenous fluid for prevention of hypothermia and shivering during caesarean delivery under spinal anaesthesia: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):442-448. doi: 10.1097/EJA.0000000000000990. PubMed 30985539 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03256786
Lead sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible party
Choi Eun MI (Clinical Professor, Hallym University Kangnam Sacred Heart Hospital) — Principal investigator
First posted
Aug 22, 2017
Start date
Jul 12, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
Feb 27, 2019

Study contacts

Eun Mi Choi, MD
study director · Hallym University Kangnam Sacred Heart Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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