Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03256786 |
|
Recruitment Status :
Completed
First Posted : August 22, 2017
Last Update Posted : February 27, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pregnancy | Behavioral: Prewarming using forced air warmer, warmed intravenous fluid |
| Study Type : | Observational |
| Actual Enrollment : | 50 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | July 12, 2017 |
| Actual Primary Completion Date : | April 30, 2018 |
| Actual Study Completion Date : | April 30, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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 |
|
Control
no preoperative warming and room temperature intravenous fluid
|
- incidence of hypothermia and shivering [ Time Frame: immediately after arrival at the postanesthesia care unit ]
- temperature of newborn [ Time Frame: immediately after delivery of newborn ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256786
| Korea, Republic of | |
| Kangnam sacred heart hospital | |
| Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013 | |
| Study Director: | Eun Mi Choi, MD | Hallym University Kangnam Sacred Heart Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Choi Eun MI, Clinical Professor, Hallym University Kangnam Sacred Heart Hospital |
| ClinicalTrials.gov Identifier: | NCT03256786 |
| Other Study ID Numbers: |
kangnamAN |
| First Posted: | August 22, 2017 Key Record Dates |
| Last Update Posted: | February 27, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
cesarean delivery with spinal anesthesia Hypothermia and shivering Active warming |
|
Hypothermia Body Temperature Changes |