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OpenTrials
Completed

NCT Number: NCT03256786

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

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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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, KS013, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prewarming using forced air warmer, warmed intravenous fluid

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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