Clinical trial NCT03256786: Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: cesarean delivery with spinal anesthesia
Hypothermia and shivering
Active warming
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cesarean delivery under spinal anesthesia

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of hypothermia and shivering
timeFrame: immediately after arrival at the postanesthesia care unit
Secondary outcomes:
measure: temperature of newborn
timeFrame: immediately after delivery of newborn
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam sacred heart hospital
state: Yeongdeungpo-gu
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Eun Mi Choi, MD
role: STUDY_DIRECTOR
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