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PregnancyNCT03256786

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

An observational study of Pregnancy, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Prewarming using forced air warmer, warmed intravenous fluid
How many people
50 participants
Where
1 siteSouth Korea
Study dates
12 Jul 2017to 30 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients scheduled for cesarean delivery under spinal anesthesia

Who may be able to join

  • Patients scheduled for cesarean delivery under spinal anesthesia
  • The American Society of Anesthesiologists physical status class one or two
  • female between 20 and 45

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangnam sacred heart hospital

    Seoul, Yeongdeungpo-gu, KS013

Other trials in South Korea

About this study

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

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.

Read more

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.

Conditions
Pregnancy
Being tested
Prewarming using forced air warmer, warmed intravenous fluid
Keywords
cesarean delivery with spinal anesthesia, Hypothermia and shivering, Active warming
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prewarming using forced air warmer, warmed intravenous fluidBehavioural

    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

Study groups in NCT03256786
Study groupRoleWhat they receive
Active warmingpreoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid
Receives: Behavioral: Prewarming using forced air warmer, warmed intravenous fluid
Controlno preoperative warming and room temperature intravenous fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of hypothermia and shivering

    Measured: immediately after arrival at the postanesthesia care unit

Secondary outcomes (1)

  1. temperature of newborn

    Measured: immediately after delivery of newborn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start12 Jul 2017
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256786
Sponsor's protocol ID
kangnamAN
Status last verified
Feb 2019
First submitted
15 Aug 2017
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of hypothermia and shivering (time frame: immediately after arrival at the postanesthesia care unit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256786, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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